montelukast 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
leukotriene receptor antagonists 1836 158966-92-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • montelukast
  • montelukast sodium
  • singulair
Montelukast is an orally active compound that binds with high affinity and selectivity to the CysLT1 receptor (in preference to other pharmacologically important airway receptors, such as the prostanoid, cholinergic, or beta-adrenergic receptor). Montelukast inhibits physiologic actions of cysteinyl leukotriene LTD4 at the CysLT1 receptor without any agonist activity.
  • Molecular weight: 586.19
  • Formula: C35H36ClNO3S
  • CLOGP: 8.33
  • LIPINSKI: 2
  • HAC: 4
  • HDO: 2
  • TPSA: 70.42
  • ALOGS: -7.85
  • ROTB: 12
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
10 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.20 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.28 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 62 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.15 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.68 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.00 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 5 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Feb. 20, 1998 FDA MERCK

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Asthma 5996.14 10.21 4069 185545 108701 55993752
Wheezing 1918.44 10.21 1762 187852 73264 56029189
Eosinophilic granulomatosis with polyangiitis 1273.65 10.21 411 189203 1650 56100803
Obstructive airways disorder 847.03 10.21 595 189019 16687 56085766
Cough 795.34 10.21 2293 187321 257668 55844785
Dyspnoea 790.13 10.21 4004 185610 588573 55513880
Sputum discoloured 638.17 10.21 465 189149 13827 56088626
Sleep disorder due to a general medical condition 602.96 10.21 378 189236 8712 56093741
Productive cough 577.96 10.21 824 188790 55408 56047045
Forced expiratory volume decreased 522.57 10.21 273 189341 4387 56098066
Pemphigus 506.74 10.21 4 189610 157208 55945245
Chest discomfort 498.29 10.21 1057 188557 97800 56004653
Full blood count abnormal 472.67 10.21 512 189102 25950 56076503
Synovitis 433.01 10.21 28 189586 161277 55941176
Rheumatoid arthritis 431.15 10.21 393 189221 382211 55720242
Hand deformity 421.61 10.21 6 189608 134486 55967967
Urticaria 388.31 10.21 1220 188394 143456 55958997
Systemic lupus erythematosus 381.89 10.21 72 189542 180006 55922447
Glossodynia 366.97 10.21 42 189572 152416 55950037
Toxicity to various agents 344.17 10.21 163 189451 224401 55878052
Treatment failure 333.03 10.21 82 189532 170310 55932143
Contraindicated product administered 319.75 10.21 114 189500 186172 55916281
Bronchitis 317.86 10.21 965 188649 111346 55991107
Arthropathy 315.21 10.21 140 189474 200135 55902318
Sinusitis 308.06 10.21 1400 188214 196181 55906272
Nasal congestion 306.41 10.21 622 188992 55748 56046705
Pericarditis 286.14 10.21 21 189593 108902 55993551
Drug intolerance 285.10 10.21 283 189331 264535 55837918
Rhinitis allergic 280.67 10.21 231 189383 8243 56094210
Upper respiratory tract infection 274.76 10.21 686 188928 70602 56031851
Joint swelling 269.24 10.21 349 189265 289451 55813002
Food allergy 264.33 10.21 227 189387 8597 56093856
Chronic obstructive pulmonary disease 260.77 10.21 589 189025 56826 56045627
Blood immunoglobulin E increased 243.03 10.21 142 189472 2867 56099586
Wound 231.29 10.21 89 189525 138715 55963738
Nasal polyps 229.74 10.21 141 189473 3124 56099329
Asthmatic crisis 226.16 10.21 112 189502 1598 56100855
Alopecia 222.12 10.21 406 189208 293052 55809401
Infusion related reaction 216.01 10.21 231 189383 208700 55893753
Therapeutic product effect decreased 215.49 10.21 154 189460 169298 55933155
Middle insomnia 213.44 10.21 222 189392 10728 56091725
Anaphylactic reaction 212.03 10.21 553 189061 58442 56044011
Pneumonia 211.65 10.21 2197 187417 404901 55697552
Sleep apnoea syndrome 204.28 10.21 337 189277 25724 56076729
Nightmare 202.06 10.21 266 189348 16560 56085893
Off label use 201.34 10.21 1078 188536 555102 55547351
Seasonal allergy 200.12 10.21 267 189347 16841 56085612
Helicobacter infection 195.67 10.21 13 189601 73255 56029198
Gastrooesophageal reflux disease 195.23 10.21 671 188943 82586 56019867
Temperature regulation disorder 194.05 10.21 143 189471 4325 56098128
Maternal exposure during pregnancy 193.24 10.21 212 189402 189341 55913112
Eosinophil count increased 188.95 10.21 196 189418 9441 56093012
Neutropenia 184.31 10.21 157 189457 158010 55944443
Influenza 179.97 10.21 716 188898 94545 56007908
Breath sounds abnormal 179.87 10.21 185 189429 8822 56093631
Impaired quality of life 178.24 10.21 179 189435 8295 56094158
Dyspnoea exertional 171.88 10.21 488 189126 54201 56048252
Therapeutic product effect incomplete 171.50 10.21 760 188854 105271 55997182
Product dose omission issue 166.85 10.21 1221 188393 203532 55898921
Polycystic ovaries 164.41 10.21 115 189499 3199 56099254
Abdominal discomfort 163.44 10.21 440 189174 276834 55825619
Completed suicide 161.93 10.21 128 189486 133705 55968748
Muscle injury 161.69 10.21 3 189611 52497 56049956
Product quality issue 159.29 10.21 339 189275 31397 56071056
Acute kidney injury 158.34 10.21 361 189253 240402 55862051
Folliculitis 155.35 10.21 7 189607 54972 56047481
Respiratory tract infection 154.86 10.21 362 189252 35709 56066744
Infective pulmonary exacerbation of cystic fibrosis 147.66 10.21 159 189455 7998 56094455
Upper-airway cough syndrome 146.87 10.21 170 189444 9268 56093185
Stomatitis 141.84 10.21 119 189495 120691 55981762
Impaired healing 139.20 10.21 59 189555 86782 56015671
Sleep terror 138.49 10.21 62 189552 694 56101759
Sensitisation 136.09 10.21 90 189524 2278 56100175
Malignant neoplasm progression 135.02 10.21 40 189574 73547 56028906
General physical health deterioration 135.00 10.21 228 189386 169782 55932671
Pancytopenia 134.82 10.21 65 189549 88650 56013803
Rhinorrhoea 134.81 10.21 461 189153 56576 56045877
Coeliac disease 134.40 10.21 170 189444 10169 56092284
Chronic spontaneous urticaria 134.35 10.21 68 189546 1019 56101434
Anaemia 131.63 10.21 461 189153 267050 55835403
Bronchospasm 130.10 10.21 208 189406 15461 56086992
Rhinitis 129.45 10.21 155 189459 8761 56093692
Secretion discharge 128.61 10.21 168 189446 10378 56092075
Drug interaction 124.93 10.21 331 189283 209424 55893029
Drug ineffective 124.19 10.21 2267 187347 916722 55185731
Thrombocytopenia 123.29 10.21 167 189447 136057 55966396
Drug abuse 121.79 10.21 38 189576 67572 56034881
Loss of personal independence in daily activities 121.67 10.21 570 189044 80799 56021654
Headache 117.72 10.21 2583 187031 556461 55545992
Blood test abnormal 117.72 10.21 178 189436 12606 56089847
Death 113.32 10.21 680 188934 340746 55761707
Febrile neutropenia 112.01 10.21 114 189500 105431 55997022
Suicidal ideation 111.41 10.21 437 189177 57305 56045148
Swelling 109.53 10.21 426 189188 239345 55863108
Dysphonia 108.89 10.21 350 189264 41597 56060856
Respiratory tract congestion 106.89 10.21 190 189424 15401 56087052
Discomfort 106.30 10.21 197 189417 141564 55960889
Reversible airways obstruction 105.71 10.21 63 189551 1321 56101132
Oropharyngeal pain 105.47 10.21 559 189055 83229 56019224
Perfume sensitivity 104.60 10.21 50 189564 657 56101796
Heart rate increased 104.43 10.21 555 189059 82718 56019735
Eczema 104.20 10.21 255 189359 25898 56076555
Anxiety 103.56 10.21 1050 188564 192122 55910331
Aggression 103.49 10.21 229 189385 21777 56080676
Ejection fraction 102.99 10.21 67 189547 1648 56100805
Musculoskeletal stiffness 102.41 10.21 234 189380 155773 55946680
Vital capacity decreased 101.96 10.21 60 189554 1228 56101225
Peak expiratory flow rate decreased 101.88 10.21 47 189567 567 56101886
Sputum increased 101.41 10.21 72 189542 2052 56100401
Hyponatraemia 97.78 10.21 120 189494 102019 56000434
Blister 95.99 10.21 136 189478 108751 55993702
Lung hyperinflation 95.34 10.21 56 189558 1142 56101311
Pruritus 93.63 10.21 1542 188072 315081 55787372
Hepatic enzyme increased 93.49 10.21 282 189332 171102 55931351
Dermatitis atopic 93.21 10.21 127 189487 8172 56094281
Total lung capacity increased 92.96 10.21 51 189563 908 56101545
Status asthmaticus 92.72 10.21 50 189564 859 56101594
Throat clearing 92.44 10.21 60 189554 1470 56100983
Eosinophilia 92.25 10.21 207 189407 19870 56082583
Disease progression 92.08 10.21 132 189482 105041 55997412
C-reactive protein abnormal 91.42 10.21 9 189605 36800 56065653
Bronchial secretion retention 88.44 10.21 63 189551 1805 56100648
Sinus disorder 87.80 10.21 207 189407 20527 56081926
Angioedema 86.77 10.21 322 189292 41131 56061322
Sleep disorder due to general medical condition, insomnia type 86.27 10.21 20 189594 43318 56059135
Immunodeficiency 86.21 10.21 177 189437 15980 56086473
Illness 86.01 10.21 284 189330 34227 56068226
Respiratory rate increased 85.01 10.21 150 189464 12087 56090366
C-reactive protein increased 84.60 10.21 84 189530 78600 56023853
Sensitivity to weather change 84.32 10.21 108 189506 6541 56095912
Leukopenia 84.32 10.21 69 189545 70871 56031582
Dust allergy 83.47 10.21 41 189573 574 56101879
Rales 83.36 10.21 139 189475 10701 56091752
Forced vital capacity decreased 82.63 10.21 48 189566 958 56101495
Intentional product use issue 82.63 10.21 130 189484 99603 56002850
Abnormal behaviour 80.06 10.21 197 189417 20075 56082378
Multiple organ dysfunction syndrome 79.65 10.21 39 189575 52731 56049722
Nasal oedema 77.16 10.21 48 189566 1090 56101363
Respiration abnormal 76.91 10.21 95 189519 5546 56096907
Sneezing 76.67 10.21 165 189449 15395 56087058
Eye pruritus 76.24 10.21 156 189458 14050 56088403
Mucosal inflammation 75.43 10.21 25 189589 42785 56059668
Multiple allergies 74.65 10.21 130 189484 10366 56092087
Intentional overdose 74.06 10.21 72 189542 68045 56034408
Gastrointestinal disorder 73.97 10.21 169 189445 112533 55989920
Hypotension 73.82 10.21 517 189097 249991 55852462
Chronic sinusitis 73.40 10.21 114 189500 8264 56094189
Irritable bowel syndrome 72.55 10.21 74 189540 68384 56034069
Confusional state 72.46 10.21 408 189206 207747 55894706
Renal impairment 71.94 10.21 100 189514 80613 56021840
Blood pressure systolic increased 70.78 10.21 299 189315 40537 56061916
Liver injury 69.37 10.21 27 189587 41821 56060632
Respiratory symptom 68.18 10.21 64 189550 2726 56099727
Throat irritation 67.66 10.21 253 189361 32430 56070023
Sinus congestion 66.59 10.21 157 189457 15567 56086886
Emphysema 66.37 10.21 120 189494 9856 56092597
Throat tightness 65.61 10.21 195 189419 22212 56080241
Septic shock 65.33 10.21 65 189549 60770 56041683
Crying 65.08 10.21 189 189425 21251 56081202
Pulmonary function test decreased 65.00 10.21 70 189544 3521 56098932
Coma 64.92 10.21 63 189551 59592 56042861
Poor quality device used 64.57 10.21 53 189561 1883 56100570
Rhonchi 64.30 10.21 58 189556 2346 56100107
Rash erythematous 63.32 10.21 271 189343 36950 56065503
Abnormal dreams 62.84 10.21 115 189499 9534 56092919
Bradycardia 62.83 10.21 81 189533 67423 56035030
Malaise 62.67 10.21 1652 187962 366208 55736245
Pulmonary function test abnormal 62.08 10.21 46 189568 1403 56101050
Toxic epidermal necrolysis 61.63 10.21 3 189611 22039 56080414
Bone marrow failure 60.55 10.21 11 189603 28275 56074178
Depressed level of consciousness 59.80 10.21 61 189553 56372 56046081
Pulmonary mass 59.80 10.21 178 189436 20292 56082161
Blood pressure increased 59.53 10.21 749 188865 144427 55958026
Sinusitis fungal 59.32 10.21 46 189568 1504 56100949
Diarrhoea 58.87 10.21 1670 187944 636837 55465616
Bronchial disorder 58.56 10.21 41 189573 1142 56101311
Red blood cell sedimentation rate increased 58.48 10.21 25 189589 36598 56065855
Asthma-chronic obstructive pulmonary disease overlap syndrome 58.16 10.21 34 189580 687 56101766
Metabolic acidosis 57.93 10.21 32 189582 40422 56062031
Nasal discharge discolouration 57.89 10.21 49 189565 1818 56100635
Hypokalaemia 57.70 10.21 147 189467 94290 56008163
Asthma exercise induced 57.62 10.21 25 189589 258 56102195
Bronchial obstruction 57.09 10.21 43 189571 1345 56101108
Insomnia 55.71 10.21 932 188682 190928 55911525
Cystic fibrosis 55.21 10.21 63 189551 3381 56099072
Bronchial neoplasm 54.14 10.21 28 189586 440 56102013
Factor V Leiden mutation 54.03 10.21 22 189592 191 56102262
Infusion site swelling 53.61 10.21 96 189518 7825 56094628
Restrictive pulmonary disease 53.48 10.21 43 189571 1483 56100970
Infusion site pruritus 53.14 10.21 73 189541 4734 56097719
Respiratory disorder 53.03 10.21 241 189373 33716 56068737
Migraine 52.94 10.21 485 189129 86312 56016141
Nasal obstruction 52.00 10.21 39 189575 1212 56101241
Haemoglobin decreased 51.64 10.21 254 189360 133883 55968570
Allergy to animal 51.04 10.21 35 189579 942 56101511
Infusion site erythema 50.97 10.21 105 189509 9501 56092952
Nasal turbinate hypertrophy 50.70 10.21 31 189583 682 56101771
Hyperkalaemia 50.54 10.21 58 189556 50807 56051646
Nasopharyngitis 50.45 10.21 1034 188580 219925 55882528
Hyper IgE syndrome 50.19 10.21 26 189588 410 56102043
Bronchial haemorrhage 49.56 10.21 28 189586 529 56101924
Mast cell activation syndrome 48.98 10.21 30 189584 662 56101791
Aspirin-exacerbated respiratory disease 48.92 10.21 33 189581 864 56101589
Mood altered 48.78 10.21 126 189488 13229 56089224
Sputum culture positive 48.58 10.21 43 189571 1696 56100757
Cardiac failure 48.46 10.21 130 189484 81963 56020490
COVID-19 48.13 10.21 424 189190 74634 56027819
Metastases to bone 47.84 10.21 5 189609 19503 56082950
Feeling abnormal 47.60 10.21 672 188942 132930 55969523
Hypoventilation 47.50 10.21 66 189548 4326 56098127
Salpingo-oophorectomy unilateral 46.44 10.21 29 189585 663 56101790
Nephrectomy 46.42 10.21 36 189578 1177 56101276
Bursitis 46.28 10.21 200 189414 27382 56075071
Aphonia 45.93 10.21 97 189517 8932 56093521
Smoke sensitivity 45.80 10.21 24 189590 388 56102065
Mobility decreased 45.69 10.21 175 189439 98816 56003637
Hip arthroplasty 45.35 10.21 38 189576 38585 56063868
Ascites 45.25 10.21 36 189578 37508 56064945
Idiopathic intracranial hypertension 44.85 10.21 49 189565 2505 56099948
Prolonged expiration 44.67 10.21 31 189583 851 56101602
Frustration tolerance decreased 44.29 10.21 78 189536 6275 56096178
Viral infection 44.26 10.21 219 189395 31727 56070726
Alanine aminotransferase increased 43.60 10.21 165 189449 93497 56008956
Arthralgia 43.41 10.21 1323 188291 500346 55602107
Live birth 43.34 10.21 7 189607 19598 56082855
Carpal tunnel syndrome 43.15 10.21 147 189467 17997 56084456
Humidity intolerance 43.01 10.21 21 189593 290 56102163
Sopor 42.96 10.21 9 189605 20913 56081540
Product use issue 42.84 10.21 410 189204 185631 55916822
Depression 42.80 10.21 848 188766 179269 55923184
Hepatotoxicity 42.68 10.21 26 189588 31127 56071326
Neoplasm progression 42.10 10.21 28 189586 31988 56070465
Scratch 41.95 10.21 71 189543 5532 56096921
Bronchiectasis 41.89 10.21 108 189506 11326 56091127
Mood swings 41.88 10.21 138 189476 16609 56085844
Haemoptysis 41.85 10.21 189 189425 26371 56076082
Platelet count decreased 41.77 10.21 200 189414 106183 55996270
Neurotoxicity 41.58 10.21 3 189611 15792 56086661
Anger 41.48 10.21 109 189505 11563 56090890
Atopy 41.27 10.21 19 189595 228 56102225
Poor quality sleep 40.61 10.21 142 189472 17613 56084840
Urticaria chronic 40.49 10.21 25 189589 560 56101893
Sepsis 39.97 10.21 291 189323 139549 55962904
Cholecystitis chronic 39.84 10.21 96 189518 9652 56092801
Inappropriate schedule of product administration 39.80 10.21 443 189171 82944 56019509
Product use in unapproved indication 39.73 10.21 681 188933 140141 55962312
Inflammation 39.55 10.21 111 189503 68960 56033493
Hereditary angioedema 38.99 10.21 77 189537 6758 56095695
Bronchopulmonary aspergillosis allergic 38.90 10.21 35 189579 1411 56101042
Burning sensation 38.76 10.21 289 189325 48407 56054046
Swelling face 38.71 10.21 322 189292 55747 56046706
Skin plaque 38.61 10.21 78 189536 6960 56095493
Liver disorder 38.51 10.21 56 189558 44314 56058139
Knee arthroplasty 38.27 10.21 56 189558 44203 56058250
Vocal cord dysfunction 38.02 10.21 21 189593 379 56102074
Total lung capacity decreased 38.02 10.21 35 189579 1454 56100999
Cardio-respiratory arrest 37.89 10.21 81 189533 55240 56047213
Infusion site pain 37.69 10.21 117 189497 13645 56088808
Increased bronchial secretion 37.63 10.21 36 189578 1571 56100882
Metastases to liver 37.34 10.21 13 189601 21573 56080880
Therapy non-responder 37.09 10.21 96 189518 61259 56041194
Fluid retention 37.03 10.21 310 189304 53768 56048685
FEV1/FVC ratio decreased 36.89 10.21 13 189601 72 56102381
Pain 36.79 10.21 1843 187771 661341 55441112
Lipohypertrophy 36.55 10.21 24 189590 600 56101853
Bone erosion 36.31 10.21 4 189610 14970 56087483
Cytomegalovirus infection 36.29 10.21 10 189604 19286 56083167
Palmar-plantar erythrodysaesthesia syndrome 35.90 10.21 13 189601 21052 56081401
Decreased appetite 35.85 10.21 521 189093 218710 55883743
Body tinea 35.52 10.21 33 189581 1387 56101066
Acute myeloid leukaemia 35.47 10.21 7 189607 16965 56085488
Agranulocytosis 35.34 10.21 16 189598 22643 56079810
Hepatocellular injury 35.12 10.21 23 189591 26491 56075962
Creatinine renal clearance decreased 35.02 10.21 4 189610 14555 56087898
Endometrial ablation 34.94 10.21 27 189587 878 56101575
Mastocytosis 34.77 10.21 22 189592 515 56101938
Lactic acidosis 34.37 10.21 41 189573 35305 56067148
White blood cell count decreased 34.19 10.21 266 189348 125724 55976729
Drug tolerance decreased 34.04 10.21 3 189611 13408 56089045
Erythema 33.69 10.21 724 188890 155215 55947238
Eosinophil count abnormal 33.52 10.21 21 189593 483 56101970
Cholestasis 33.46 10.21 25 189589 26888 56075565
Oxygen saturation decreased 33.27 10.21 410 189204 78657 56023796
Skin ulcer 33.24 10.21 49 189565 38559 56063894
Ear pruritus 33.17 10.21 45 189569 2883 56099570
Biliary dyskinesia 33.08 10.21 42 189572 2521 56099932
Inhibitory drug interaction 32.80 10.21 40 189574 2304 56100149
Aspartate aminotransferase increased 32.59 10.21 155 189459 82447 56020006
Rash 32.39 10.21 1345 188269 491702 55610751
Encephalopathy 32.24 10.21 43 189571 35282 56067171
Pulmonary pain 32.23 10.21 44 189570 2836 56099617
Gastrointestinal haemorrhage 32.07 10.21 139 189475 75812 56026641
Dehydration 32.06 10.21 361 189253 158464 55943989
Bronchitis chronic 31.82 10.21 52 189562 3936 56098517
Infection 31.62 10.21 479 189135 199727 55902726
Heart sounds 31.42 10.21 24 189590 767 56101686
Cardiac arrest 31.19 10.21 167 189447 86147 56016306
Increased viscosity of bronchial secretion 31.07 10.21 16 189598 249 56102204
Ear infection 31.00 10.21 196 189418 31099 56071354
Irritability 31.00 10.21 188 189426 29400 56073053
Neutrophil count decreased 30.85 10.21 77 189537 49745 56052708
Respiratory tract inflammation 30.79 10.21 21 189593 560 56101893
Anosmia 30.48 10.21 54 189560 4365 56098088
Blood creatinine increased 30.19 10.21 153 189461 80038 56022415
Pharyngeal oedema 30.17 10.21 106 189508 13179 56089274
Chest pain 30.13 10.21 845 188769 188952 55913501
Swollen tongue 30.09 10.21 190 189424 30134 56072319
Spirometry abnormal 30.04 10.21 15 189599 218 56102235
Eosinophilic pneumonia 29.74 10.21 35 189579 1942 56100511
Condition aggravated 29.66 10.21 910 188704 343988 55758465
Embolism venous 29.61 10.21 42 189572 2806 56099647
Infusion site extravasation 29.51 10.21 77 189537 8133 56094320
Circulatory collapse 29.00 10.21 17 189597 20786 56081667
Infection susceptibility increased 28.88 10.21 41 189573 2742 56099711
Colitis 28.81 10.21 61 189553 41750 56060703
Blood cholesterol increased 28.75 10.21 136 189478 72443 56030010
Stress 28.58 10.21 314 189300 58596 56043857
Neutropenic sepsis 28.31 10.21 8 189606 15177 56087276
Lip swelling 28.20 10.21 168 189446 26104 56076349
Osteonecrosis of jaw 28.07 10.21 43 189571 33315 56069138
Infusion site haemorrhage 27.90 10.21 47 189567 3648 56098805
Cardiac disorder 27.76 10.21 256 189358 45631 56056822
Interstitial lung disease 27.55 10.21 99 189515 56964 56045489
Occupational asthma 27.48 10.21 12 189602 126 56102327
Neurosensory hypoacusis 27.47 10.21 14 189600 213 56102240
Psoriatic arthropathy 27.40 10.21 142 189472 73866 56028587
Disseminated intravascular coagulation 27.32 10.21 13 189601 17872 56084581
Hypocalcaemia 27.29 10.21 34 189580 28726 56073727
Mite allergy 27.08 10.21 19 189595 531 56101922
Respiratory gas exchange disorder 27.08 10.21 16 189598 330 56102123
Pneumonia aspiration 27.06 10.21 42 189572 32369 56070084
Delirium 26.88 10.21 65 189549 42452 56060001
Glucose tolerance impaired 26.69 10.21 58 189556 5447 56097006
Rash maculo-papular 26.57 10.21 35 189579 28872 56073581
Hypomagnesaemia 26.54 10.21 27 189587 24988 56077465
Renal failure 26.50 10.21 241 189373 110259 55992194
Anuria 26.44 10.21 4 189610 11756 56090697
Ejection fraction abnormal 26.44 10.21 25 189589 1075 56101378
Quality of life decreased 26.28 10.21 67 189547 6978 56095475
Hypercapnia 26.21 10.21 55 189559 5041 56097412
Drug level increased 26.09 10.21 19 189595 20706 56081747
Affective disorder 25.99 10.21 58 189556 5545 56096908
Orthostatic hypotension 25.88 10.21 45 189569 33154 56069299
Rhabdomyolysis 25.83 10.21 62 189552 40596 56061857
Pneumothorax spontaneous 25.76 10.21 21 189593 739 56101714
Breast cancer metastatic 25.60 10.21 10 189604 15459 56086994
Blood creatine phosphokinase increased 25.53 10.21 34 189580 27918 56074535
Lymphocyte count decreased 25.50 10.21 34 189580 27905 56074548
Paranasal sinus discomfort 25.48 10.21 43 189571 3342 56099111
Increased upper airway secretion 24.91 10.21 42 189572 3262 56099191
Pharyngeal swelling 24.70 10.21 55 189559 5251 56097202
Nocturnal fear 24.04 10.21 6 189608 6 56102447
Ear discomfort 23.94 10.21 65 189549 7030 56095423
Influenza like illness 23.84 10.21 312 189302 60676 56041777
Ankle fracture 23.83 10.21 114 189500 16289 56086164
Vomiting 23.76 10.21 1405 188209 496823 55605630
Infusion site urticaria 23.73 10.21 25 189589 1226 56101227
Premature delivery 23.63 10.21 34 189580 27026 56075427
Lung opacity 23.57 10.21 34 189580 2307 56100146
Pharyngitis streptococcal 23.51 10.21 78 189536 9420 56093033
Gamma-glutamyltransferase increased 23.29 10.21 43 189571 30962 56071491
Peripheral swelling 23.03 10.21 608 189006 234118 55868335
Joint range of motion decreased 23.02 10.21 31 189583 25334 56077119
Progressive multifocal leukoencephalopathy 23.02 10.21 6 189608 12007 56090446
Hepatic failure 22.95 10.21 49 189565 33437 56069016
Infusion site bruising 22.92 10.21 37 189577 2772 56099681
Palpitations 22.89 10.21 467 189147 99205 56003248
Acute respiratory distress syndrome 22.89 10.21 24 189590 21902 56080551
Bronchial hyperreactivity 22.77 10.21 27 189587 1510 56100943
Mononeuropathy multiplex 22.71 10.21 13 189601 252 56102201
Spinal operation 22.47 10.21 65 189549 7291 56095162
Product substitution issue 22.34 10.21 103 189511 14496 56087957
Hyperhidrosis 22.33 10.21 443 189171 93645 56008808
Separation anxiety disorder 22.32 10.21 7 189607 25 56102428
Ligament pain 22.21 10.21 12 189602 207 56102246
Allergy test positive 22.16 10.21 15 189599 395 56102058
Lacrimation increased 22.10 10.21 121 189493 18227 56084226
Oral allergy syndrome 21.91 10.21 7 189607 27 56102426
Incorrect dose administered 21.89 10.21 272 189342 52275 56050178
Blood bilirubin increased 21.88 10.21 50 189564 33304 56069149
Lung diffusion test decreased 21.75 10.21 18 189596 647 56101806
Somnambulism 21.73 10.21 51 189563 5041 56097412
Hepatic function abnormal 21.72 10.21 53 189561 34505 56067948
Pulmonary arterial hypertension 21.51 10.21 35 189579 26468 56075985
Neuroleptic malignant syndrome 21.49 10.21 6 189608 11472 56090981
Serotonin syndrome 21.48 10.21 35 189579 26455 56075998
Sarcoidosis 21.36 10.21 53 189561 5427 56097026
Lower respiratory tract congestion 21.24 10.21 33 189581 2393 56100060
Product container issue 21.18 10.21 26 189588 1508 56100945
Airway remodelling 21.13 10.21 8 189606 56 56102397
Choking sensation 20.98 10.21 39 189575 3272 56099181
Upper airway obstruction 20.95 10.21 17 189597 594 56101859
Nasal inflammation 20.93 10.21 15 189599 434 56102019
Body temperature decreased 20.87 10.21 118 189496 17990 56084463
Anaphylactic shock 20.82 10.21 135 189479 21605 56080848
Educational problem 20.81 10.21 14 189600 365 56102088
Muscle spasticity 20.66 10.21 22 189592 19938 56082515
Exposure to allergen 20.64 10.21 12 189602 240 56102213
Expiratory reserve volume decreased 20.62 10.21 7 189607 34 56102419
Lung disorder 20.53 10.21 269 189345 52328 56050125
Eye paraesthesia 20.40 10.21 9 189605 97 56102356
Weight decreased 20.21 10.21 998 188616 239716 55862737
Cardiac murmur 20.15 10.21 84 189530 11317 56091136
Paraesthesia oral 19.97 10.21 99 189515 14350 56088103
Hysterectomy 19.90 10.21 69 189545 8522 56093931
Appetite disorder 19.89 10.21 58 189556 6535 56095918
Myalgia 19.89 10.21 584 189030 131441 55971012
Metastases to central nervous system 19.83 10.21 8 189606 12128 56090325
CFTR gene mutation 19.77 10.21 9 189605 105 56102348
Eosinophilic oesophagitis 19.58 10.21 12 189602 265 56102188
Sinus operation 19.54 10.21 29 189585 2019 56100434
Inappropriate antidiuretic hormone secretion 19.52 10.21 11 189603 13745 56088708
Blood pressure fluctuation 19.50 10.21 70 189544 40290 56062163
Dyspnoea at rest 19.44 10.21 41 189573 3772 56098681
Weight increased 19.41 10.21 953 188661 228750 55873703
Sedation 19.23 10.21 57 189557 34797 56067656
Injection site movement impairment 19.23 10.21 6 189608 21 56102432
Tenosynovitis 19.12 10.21 9 189605 12452 56090001
Drug eruption 19.11 10.21 36 189578 25727 56076726
Conjunctivitis allergic 19.11 10.21 18 189596 770 56101683
Colitis ulcerative 19.06 10.21 33 189581 24358 56078095
Torsade de pointes 19.06 10.21 9 189605 12431 56090022
Pleural effusion 18.97 10.21 190 189424 85290 56017163
Thinking abnormal 18.97 10.21 75 189539 9866 56092587
Cerebral infarction 18.95 10.21 29 189585 22476 56079977
Cognitive disorder 18.91 10.21 93 189521 49040 56053413
Adrenal suppression 18.90 10.21 19 189595 881 56101572
Airway peak pressure increased 18.89 10.21 12 189602 283 56102170
Gluten sensitivity 18.81 10.21 15 189599 511 56101942
Atrial fibrillation 18.77 10.21 256 189358 108641 55993812
Panniculitis 18.70 10.21 5 189609 9837 56092616
Obstruction 18.68 10.21 31 189583 2377 56100076
Depressed mood 18.65 10.21 196 189418 36163 56066290
Sleep disorder 18.62 10.21 326 189288 67337 56035116
Tuberculosis 18.47 10.21 7 189607 11022 56091431
Mycotic allergy 18.39 10.21 18 189596 808 56101645
Stevens-Johnson syndrome 18.32 10.21 30 189584 22633 56079820
Paranoia 18.09 10.21 78 189536 10666 56091787
Joint stiffness 18.08 10.21 60 189554 35365 56067088
Hypoglycaemia 18.01 10.21 112 189502 55703 56046750
Drug resistance 17.75 10.21 26 189588 20516 56081937
Nervousness 17.61 10.21 162 189452 28853 56073600
Bacteraemia 17.60 10.21 16 189598 15615 56086838
Lactose intolerance 17.59 10.21 32 189582 2640 56099813
Sinus polyp 17.53 10.21 12 189602 322 56102131
Pregnancy 17.52 10.21 55 189559 32978 56069475
Acute hepatic failure 17.47 10.21 18 189596 16560 56085893
Foetal exposure during pregnancy 17.46 10.21 57 189557 33766 56068687
Acute sinusitis 17.44 10.21 38 189576 3575 56098878
Skin necrosis 17.38 10.21 10 189604 12351 56090102
Injection site scab 17.36 10.21 13 189601 403 56102050
Allergic sinusitis 17.33 10.21 16 189598 667 56101786
Hypoalbuminaemia 17.30 10.21 7 189607 10592 56091861
Pulmonary thrombosis 17.29 10.21 63 189551 7974 56094479
Oropharyngeal discomfort 17.19 10.21 43 189571 4425 56098028
Oesophageal dilatation 17.09 10.21 12 189602 336 56102117
Ill-defined disorder 17.09 10.21 148 189466 68395 56034058
Pneumococcal infection 17.06 10.21 13 189601 414 56102039
Foot deformity 17.06 10.21 34 189580 23791 56078662
Ulcer 17.05 10.21 31 189583 22454 56079999
Pulmonary toxicity 17.01 10.21 3 189611 7880 56094573
Administration site erythema 16.98 10.21 15 189599 590 56101863
Cortisol decreased 16.96 10.21 20 189594 1112 56101341
Ischaemic stroke 16.95 10.21 19 189595 16823 56085630
Nephropathy toxic 16.84 10.21 4 189610 8523 56093930
Pre-existing condition improved 16.77 10.21 59 189555 7339 56095114
Hypercalcaemia 16.74 10.21 38 189576 25373 56077080
Respiratory tract irritation 16.66 10.21 13 189601 429 56102024
Cytopenia 16.66 10.21 6 189608 9749 56092704
Blood alkaline phosphatase increased 16.60 10.21 71 189543 38874 56063579
Night sweats 16.45 10.21 77 189537 41136 56061317
Hiatus hernia 16.42 10.21 118 189496 19534 56082919
Epilepsy 16.41 10.21 38 189576 25193 56077260
Drug reaction with eosinophilia and systemic symptoms 16.40 10.21 50 189564 30254 56072199
Bronchial irritation 16.36 10.21 5 189609 16 56102437
Intentional product misuse 16.28 10.21 104 189510 51400 56051053
Blood immunoglobulin E decreased 16.24 10.21 7 189607 71 56102382
Exposure during pregnancy 16.18 10.21 343 189271 135999 55966454
Oxygen consumption decreased 16.08 10.21 10 189604 227 56102226
Bronchial wall thickening 16.05 10.21 19 189595 1061 56101392
Prescribed underdose 16.02 10.21 28 189586 20589 56081864
Myelodysplastic syndrome 15.98 10.21 19 189595 16387 56086066
Nodular vasculitis 15.91 10.21 5 189609 18 56102435
Neurogenic shock 15.79 10.21 11 189603 304 56102149
Vocal cord disorder 15.76 10.21 21 189593 1322 56101131
Liver function test abnormal 15.60 10.21 90 189524 45581 56056872
Product contamination physical 15.58 10.21 7 189607 79 56102374
Peritonitis 15.53 10.21 19 189595 16183 56086270
Pneumocystis jirovecii pneumonia 15.49 10.21 18 189596 15683 56086770
Candida infection 15.42 10.21 143 189471 25524 56076929
Eye swelling 15.41 10.21 124 189490 21252 56081201
Sinus headache 15.33 10.21 44 189570 4914 56097539
Muscle tension dysphonia 15.21 10.21 7 189607 84 56102369
Acute myocardial infarction 15.16 10.21 52 189562 30341 56072112
Fungal infection 15.15 10.21 174 189440 32819 56069634
Tic 15.11 10.21 20 189594 1251 56101202
Decubitus ulcer 15.09 10.21 7 189607 9768 56092685
Miller Fisher syndrome 14.92 10.21 7 189607 88 56102365
Osteomyelitis 14.78 10.21 38 189576 24308 56078145
Rhinitis perennial 14.78 10.21 5 189609 24 56102429
Laryngitis fungal 14.75 10.21 8 189606 139 56102314
Ligament sprain 14.72 10.21 77 189537 11398 56091055
Lymphopenia 14.72 10.21 21 189593 16753 56085700
Altered state of consciousness 14.71 10.21 35 189579 22986 56079467
Depressive symptom 14.61 10.21 35 189579 3506 56098947
Blood parathyroid hormone decreased 14.53 10.21 5 189609 8359 56094094
Blood calcium decreased 14.51 10.21 37 189577 23732 56078721
Gallbladder disorder 14.43 10.21 104 189510 17230 56085223
Metastases to lung 14.42 10.21 11 189603 11707 56090746
Hypothyroidism 14.35 10.21 194 189420 38002 56064451
Upper limb fracture 14.32 10.21 103 189511 17052 56085401
Pulmonary embolism 14.31 10.21 467 189147 106657 55995796
Injection site pain 14.24 10.21 505 189109 116613 55985840
Product packaging confusion 14.12 10.21 8 189606 152 56102301
Premature baby 14.10 10.21 27 189587 19178 56083275
Defiant behaviour 14.09 10.21 3 189611 0 56102453
Pulmonary function challenge test abnormal 14.09 10.21 3 189611 0 56102453
Sleep study abnormal 14.09 10.21 3 189611 0 56102453
Glomus tumour 14.09 10.21 3 189611 0 56102453
Lip discolouration 14.08 10.21 13 189601 542 56101911
Diverticulum 14.02 10.21 74 189540 10992 56091461
Ear swelling 14.01 10.21 19 189595 1217 56101236
Electrocardiogram QT prolonged 13.99 10.21 117 189497 54471 56047982
Accidental overdose 13.97 10.21 30 189584 20431 56082022
Fracture pain 13.89 10.21 11 189603 371 56102082
Acute generalised exanthematous pustulosis 13.85 10.21 8 189606 9861 56092592
Transaminases increased 13.83 10.21 50 189564 28720 56073733
Anticholinergic syndrome 13.81 10.21 24 189590 1910 56100543
Otorrhoea 13.76 10.21 20 189594 1367 56101086
Melaena 13.71 10.21 49 189565 28241 56074212
Squamous cell carcinoma of the oral cavity 13.70 10.21 10 189604 298 56102155
Respiratory tract infection viral 13.66 10.21 24 189590 1927 56100526
Cytokine release syndrome 13.65 10.21 10 189604 10865 56091588
Distal intestinal obstruction syndrome 13.64 10.21 11 189603 381 56102072
Mucosal discolouration 13.61 10.21 12 189602 471 56101982
Facet joint syndrome 13.57 10.21 3 189611 6714 56095739
Therapeutic response unexpected 13.47 10.21 101 189513 16943 56085510
Diabetic ketoacidosis 13.45 10.21 27 189587 18844 56083609
Unresponsive to stimuli 13.43 10.21 58 189556 31667 56070786
PCO2 increased 13.31 10.21 18 189596 1150 56101303
Forced expiratory volume 13.28 10.21 4 189610 12 56102441
Lung diffusion disorder 13.26 10.21 6 189608 69 56102384
Temperature intolerance 13.26 10.21 58 189556 7982 56094471
Emotional distress 13.24 10.21 156 189458 29607 56072846
Dysphemia 13.18 10.21 27 189587 2433 56100020
Sputum retention 13.17 10.21 12 189602 492 56101961
Mandibular mass 13.16 10.21 8 189606 174 56102279
Muscle rigidity 13.15 10.21 10 189604 10661 56091792
Functional residual capacity increased 13.11 10.21 6 189608 71 56102382
Haemophagocytic lymphohistiocytosis 13.09 10.21 8 189606 9564 56092889
Vaccination site swelling 13.08 10.21 5 189609 36 56102417
Hepatic encephalopathy 13.08 10.21 9 189605 10101 56092352
Body temperature abnormal 13.08 10.21 21 189593 1566 56100887
Female genital tract fistula 13.06 10.21 39 189575 4453 56098000
Hospitalisation 13.05 10.21 338 189276 74662 56027791
Frequent bowel movements 13.04 10.21 22 189592 16402 56086051
Posterior reversible encephalopathy syndrome 13.02 10.21 21 189593 15939 56086514
Injection site hypoaesthesia 13.02 10.21 11 189603 407 56102046
Oesophagogastroduodenoscopy 12.99 10.21 7 189607 120 56102333
Left ventricular dysfunction 12.99 10.21 11 189603 11112 56091341
Forced expiratory volume abnormal 12.96 10.21 6 189608 73 56102380
Sinus bradycardia 12.95 10.21 16 189598 13570 56088883
Product taste abnormal 12.93 10.21 23 189591 1865 56100588
Uveitis 12.92 10.21 11 189603 11084 56091369
Overdose 12.92 10.21 265 189349 105565 55996888
Cold agglutinins positive 12.85 10.21 5 189609 38 56102415
Female reproductive neoplasm 12.85 10.21 5 189609 38 56102415
Musculoskeletal pain 12.85 10.21 194 189420 80958 56021495
Flushing 12.81 10.21 318 189296 69782 56032671
Diastolic dysfunction 12.78 10.21 45 189569 5600 56096853
Schizophrenia 12.74 10.21 10 189604 10489 56091964
Speech disorder 12.70 10.21 187 189427 37306 56065147
Proteinuria 12.64 10.21 25 189589 17545 56084908
Product appearance confusion 12.63 10.21 5 189609 40 56102413
Hypothermia 12.62 10.21 14 189600 12456 56089997
Laryngeal oedema 12.61 10.21 43 189571 5267 56097186
Eczema impetiginous 12.61 10.21 4 189610 15 56102438
Hypersensitivity 12.60 10.21 1015 188599 255393 55847060
Female sterilisation 12.55 10.21 12 189602 523 56101930
Administration site swelling 12.54 10.21 17 189597 1088 56101365
Functional residual capacity decreased 12.54 10.21 6 189608 79 56102374
Forced expiratory flow decreased 12.54 10.21 6 189608 79 56102374
Diffuse large B-cell lymphoma 12.53 10.21 4 189610 7012 56095441
Oropharyngitis fungal 12.53 10.21 5 189609 41 56102412
Inhalation therapy 12.53 10.21 5 189609 41 56102412
Neuropsychiatric syndrome 12.53 10.21 5 189609 41 56102412
Pulmonary eosinophilia 12.51 10.21 9 189605 262 56102191
Middle ear effusion 12.48 10.21 25 189589 2217 56100236
Product dispensing error 12.47 10.21 63 189551 9201 56093252
Abnormal weight gain 12.42 10.21 20 189594 1495 56100958
Skin lesion 12.31 10.21 147 189467 27988 56074465
Product availability issue 12.30 10.21 30 189584 3039 56099414
Snoring 12.28 10.21 33 189581 3548 56098905
Systemic mastocytosis 12.25 10.21 8 189606 198 56102255
Low birth weight baby 12.23 10.21 3 189611 6255 56096198
Infusion site nodule 12.23 10.21 18 189596 1244 56101209
Hypereosinophilic syndrome 12.22 10.21 9 189605 272 56102181
Hallucination 12.19 10.21 233 189381 48916 56053537
Administration site pruritus 12.19 10.21 9 189605 273 56102180
Breast cancer stage I 12.15 10.21 3 189611 6227 56096226
Jaundice 12.11 10.21 49 189565 27245 56075208
Polymorphic eruption of pregnancy 12.02 10.21 3 189611 3 56102450
Platelet adhesiveness decreased 12.02 10.21 3 189611 3 56102450
Basal cell carcinoma 12.01 10.21 44 189570 25177 56077276
Plasma cell myeloma 11.95 10.21 100 189514 46546 56055907
Cardiogenic shock 11.94 10.21 23 189591 16302 56086151
Cephalo-pelvic disproportion 11.94 10.21 8 189606 207 56102246
Stress urinary incontinence 11.94 10.21 24 189590 2134 56100319
Exposure to fungus 11.91 10.21 7 189607 143 56102310
SARS-CoV-2 test positive 11.89 10.21 47 189567 6182 56096271
Diverticulum oesophageal 11.86 10.21 7 189607 144 56102309
Laryngeal stenosis 11.85 10.21 15 189599 898 56101555
Malnutrition 11.84 10.21 18 189596 13990 56088463
Atrioventricular block first degree 11.83 10.21 4 189610 6761 56095692
Renal disorder 11.80 10.21 152 189462 29453 56073000
Neoplasm malignant 11.73 10.21 49 189565 27006 56075447
Pneumonia respiratory syncytial viral 11.67 10.21 13 189601 679 56101774
Self-injurious ideation 11.67 10.21 25 189589 2325 56100128
Painful respiration 11.64 10.21 26 189588 2488 56099965
Fear 11.59 10.21 88 189526 14820 56087633
Clostridium difficile colitis 11.57 10.21 29 189585 18709 56083744
Coagulopathy 11.53 10.21 29 189585 18687 56083766
Device expulsion 11.51 10.21 58 189556 30391 56072062
Hyperplastic cholecystopathy 11.50 10.21 6 189608 96 56102357
Aplastic anaemia 11.48 10.21 8 189606 8920 56093533
Animal scratch 11.48 10.21 16 189598 1052 56101401
International normalised ratio increased 11.47 10.21 94 189520 43947 56058506
Mycobacterium avium complex infection 11.45 10.21 28 189586 2841 56099612
Poisoning deliberate 11.43 10.21 10 189604 9943 56092510
Dyslipidaemia 11.38 10.21 47 189567 6306 56096147
Miosis 11.35 10.21 4 189610 6588 56095865
Screaming 11.34 10.21 29 189585 3025 56099428
Phlebectomy 11.33 10.21 5 189609 54 56102399
Ejection fraction decreased 11.27 10.21 32 189582 19809 56082644
Blood lactate dehydrogenase increased 11.27 10.21 34 189580 20641 56081812
Pulmonary renal syndrome 11.24 10.21 10 189604 397 56102056
Infusion site warmth 11.22 10.21 19 189595 1481 56100972
Respiratory arrest 11.20 10.21 59 189555 30566 56071887
Hyperventilation 11.09 10.21 43 189571 5605 56096848
Cerebral haemorrhage 11.09 10.21 54 189560 28552 56073901
Sputum culture 11.06 10.21 7 189607 164 56102289
Back pain 11.04 10.21 935 188679 236235 55866218
Oral pruritus 11.04 10.21 21 189593 1793 56100660
Neuropathy peripheral 11.02 10.21 263 189351 102630 55999823
Glossitis 11.02 10.21 27 189587 2743 56099710
Obsessive thoughts 10.96 10.21 11 189603 509 56101944
Hypertensive crisis 10.96 10.21 19 189595 14017 56088436
Face injury 10.95 10.21 28 189586 2921 56099532
Dizziness 10.88 10.21 1436 188178 374704 55727749
Hepatic cirrhosis 10.86 10.21 36 189578 21227 56081226
Hearing aid user 10.86 10.21 5 189609 60 56102393
Overweight 10.82 10.21 30 189584 3284 56099169
Peak expiratory flow rate increased 10.81 10.21 3 189611 6 56102447
Vaccination complication 10.79 10.21 15 189599 984 56101469
Serum sickness 10.78 10.21 26 189588 2616 56099837
PO2 decreased 10.70 10.21 18 189596 1395 56101058
Femur fracture 10.63 10.21 83 189531 39212 56063241
Unintentional medical device removal 10.62 10.21 3 189611 5691 56096762
Blood immunoglobulin G decreased 10.56 10.21 23 189591 2163 56100290
Abdominal pain lower 10.53 10.21 41 189573 23051 56079402
Prothrombin time prolonged 10.53 10.21 9 189605 9051 56093402
Congenital naevus 10.52 10.21 7 189607 179 56102274
Status epilepticus 10.51 10.21 22 189592 15119 56087334
School refusal 10.50 10.21 3 189611 7 56102446
Mouth swelling 10.46 10.21 34 189580 4063 56098390
Pertussis 10.41 10.21 12 189602 651 56101802
Vaccination site pain 10.41 10.21 6 189608 118 56102335
COVID-19 immunisation 10.39 10.21 18 189596 1429 56101024
Mechanical urticaria 10.36 10.21 10 189604 441 56102012
Intestinal perforation 10.35 10.21 13 189601 10946 56091507
Urinary retention 10.31 10.21 54 189560 28020 56074433
Breast cancer female 10.29 10.21 16 189598 12322 56090131
Oliguria 10.29 10.21 8 189606 8432 56094021
Skin sensitisation 10.23 10.21 13 189601 781 56101672
Alice in wonderland syndrome 10.22 10.21 4 189610 31 56102422

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Asthma 3769.19 11.17 1900 74440 40711 31580293
Wheezing 1299.64 11.17 901 75439 35085 31585919
Eosinophilic granulomatosis with polyangiitis 847.02 11.17 263 76077 1368 31619636
Obstructive airways disorder 736.70 11.17 429 75911 12235 31608769
Cough 499.92 11.17 1041 75299 133773 31487231
Full blood count abnormal 483.42 11.17 363 75977 15984 31605020
Forced expiratory volume decreased 433.50 11.17 188 76152 2789 31618215
Sleep terror 409.62 11.17 126 76214 631 31620373
Productive cough 378.99 11.17 435 75905 33105 31587899
Dyspnoea 359.73 11.17 1704 74636 341775 31279229
Abnormal behaviour 344.42 11.17 352 75988 23476 31597528
Suicidal ideation 342.19 11.17 430 75910 35976 31585028
Sleep disorder due to a general medical condition 303.10 11.17 160 76180 3742 31617262
Therapeutic product effect incomplete 293.98 11.17 439 75901 43257 31577747
Aggression 277.52 11.17 393 75947 36898 31584106
Nightmare 276.02 11.17 231 76109 11906 31609098
Toxicity to various agents 271.14 11.17 54 76286 181433 31439571
Nasal congestion 239.72 11.17 270 76070 20111 31600893
Chest discomfort 237.16 11.17 426 75914 48943 31572061
Anger 236.67 11.17 204 76136 10949 31610055
Sputum discoloured 235.53 11.17 166 76174 6610 31614394
Middle insomnia 229.78 11.17 157 76183 5942 31615062
Sinusitis 223.30 11.17 352 75988 36344 31584660
Blood immunoglobulin E increased 209.59 11.17 104 76236 2127 31618877
Acute kidney injury 186.17 11.17 241 76099 279473 31341531
Nasal polyps 180.73 11.17 91 76249 1922 31619082
Loss of personal independence in daily activities 178.54 11.17 276 76064 28012 31592992
Anaemia 169.44 11.17 159 76181 213363 31407641
Anxiety 158.59 11.17 531 75809 90502 31530502
Depression 144.47 11.17 514 75826 90301 31530703
Pulmonary function test decreased 137.67 11.17 101 76239 4284 31616720
Mood altered 134.73 11.17 131 76209 8215 31612789
Bronchial wall thickening 128.96 11.17 61 76279 1118 31619886
Bronchiectasis 128.07 11.17 122 76218 7458 31613546
Chronic obstructive pulmonary disease 125.80 11.17 312 76028 44854 31576150
Death 123.06 11.17 451 75889 360118 31260886
Infective pulmonary exacerbation of cystic fibrosis 120.41 11.17 110 76230 6374 31614630
Crying 119.99 11.17 103 76237 5494 31615510
Urticaria 118.86 11.17 356 75984 57161 31563843
Gastrooesophageal reflux disease 118.55 11.17 256 76084 33615 31587389
Thrombocytopenia 117.03 11.17 103 76237 142644 31478360
Drug interaction 115.95 11.17 203 76137 208340 31412664
Eosinophilia 110.72 11.17 200 76140 23053 31597951
Rhinorrhoea 107.13 11.17 196 76144 22816 31598188
Febrile neutropenia 105.93 11.17 83 76257 121766 31499238
Bronchial secretion retention 105.78 11.17 55 76285 1245 31619759
Pulmonary function test abnormal 105.21 11.17 66 76274 2155 31618849
Nasopharyngitis 102.25 11.17 360 75980 62885 31558119
Eosinophil count increased 101.59 11.17 109 76231 7682 31613322
Off label use 96.38 11.17 470 75870 346804 31274200
Asthmatic crisis 95.96 11.17 38 76302 441 31620563
Asthma-chronic obstructive pulmonary disease overlap syndrome 94.72 11.17 46 76294 896 31620108
Seasonal allergy 94.52 11.17 90 76250 5498 31615506
Sleep disorder 93.17 11.17 200 76140 26148 31594856
Rhinitis 92.26 11.17 85 76255 4979 31616025
Bronchitis 91.95 11.17 252 76088 38465 31582539
Impaired quality of life 90.60 11.17 72 76268 3444 31617560
Hypotension 88.76 11.17 229 76111 204389 31416615
Upper-airway cough syndrome 86.99 11.17 67 76273 3060 31617944
Bronchial hyperreactivity 86.74 11.17 50 76290 1395 31619609
Influenza 86.54 11.17 269 76071 44056 31576948
Right atrial hypertrophy 86.09 11.17 38 76302 589 31620415
Bronchospasm 84.52 11.17 112 76228 9860 31611144
Dyspnoea exertional 81.73 11.17 242 76098 38595 31582409
Pancytopenia 81.69 11.17 55 76285 87261 31533743
Sensitivity to weather change 79.76 11.17 48 76292 1453 31619551
Malignant neoplasm progression 79.09 11.17 46 76294 78952 31542052
Drug abuse 78.51 11.17 58 76282 87700 31533304
Neutropenia 78.49 11.17 136 76204 140228 31480776
Bronchial obstruction 78.39 11.17 47 76293 1413 31619591
Irritability 77.79 11.17 171 76169 22718 31598286
Multiple organ dysfunction syndrome 76.82 11.17 34 76306 68169 31552835
Tic 76.04 11.17 51 76289 1870 31619134
Vital capacity decreased 75.85 11.17 30 76310 347 31620657
Blood creatinine increased 75.73 11.17 62 76278 89016 31531988
Sepsis 73.83 11.17 160 76180 151769 31469235
Photodermatosis 73.50 11.17 32 76308 479 31620525
Hypersensitivity 73.25 11.17 297 76043 55446 31565558
Dysplastic naevus 71.94 11.17 31 76309 452 31620552
Mood swings 71.75 11.17 89 76251 7335 31613669
Solar lentigo 71.32 11.17 31 76309 462 31620542
Ear infection 71.07 11.17 97 76243 8784 31612220
Eosinophilic pneumonia chronic 70.28 11.17 26 76314 247 31620757
Hyponatraemia 69.68 11.17 46 76294 73753 31547251
Obstruction 68.95 11.17 50 76290 2082 31618922
Screaming 68.41 11.17 42 76298 1319 31619685
Bronchopulmonary aspergillosis allergic 67.38 11.17 32 76308 592 31620412
Lower respiratory tract infection 67.24 11.17 184 76156 28053 31592951
Dermatitis atopic 66.90 11.17 70 76270 4792 31616212
Psychomotor hyperactivity 65.87 11.17 93 76247 8694 31612310
Allergy to animal 64.81 11.17 25 76315 269 31620735
Sneezing 64.56 11.17 68 76272 4691 31616313
Leukopenia 63.29 11.17 30 76310 57798 31563206
Headache 62.26 11.17 696 75644 182956 31438048
Breath sounds abnormal 62.22 11.17 74 76266 5838 31615166
Eye pruritus 61.28 11.17 68 76272 4977 31616027
Right ventricular hypertrophy 60.78 11.17 38 76302 1233 31619771
Sleep apnoea syndrome 59.76 11.17 136 76204 18489 31602515
Haemoglobin decreased 59.53 11.17 113 76227 112562 31508442
Confusional state 59.46 11.17 147 76193 133187 31487817
Vocal cord dysfunction 59.13 11.17 20 76320 142 31620862
Multiple allergies 58.79 11.17 48 76292 2387 31618617
Respiratory tract congestion 58.17 11.17 69 76271 5428 31615576
Aspirin-exacerbated respiratory disease 57.68 11.17 25 76315 370 31620634
Blood cholesterol 57.66 11.17 21 76319 190 31620814
Renal failure 57.34 11.17 133 76207 123197 31497807
Diarrhoea 57.28 11.17 558 75782 351851 31269153
Depressed mood 57.13 11.17 129 76211 17446 31603558
Upper respiratory tract infection 56.89 11.17 178 76162 29244 31591760
Victim of child abuse 55.93 11.17 32 76308 880 31620124
Social avoidant behaviour 55.72 11.17 51 76289 2962 31618042
Completed suicide 55.50 11.17 84 76256 91430 31529574
Rhinitis perennial 55.33 11.17 23 76317 305 31620699
Insomnia 54.44 11.17 403 75937 94433 31526571
Osteoporosis 54.33 11.17 99 76241 11484 31609520
Sputum increased 53.30 11.17 43 76297 2102 31618902
Rhabdomyolysis 53.10 11.17 45 76295 63536 31557468
Product dose omission issue 53.04 11.17 435 75905 105151 31515853
Heart rate increased 52.38 11.17 217 76123 40893 31580111
Nasal disorder 52.30 11.17 39 76301 1696 31619308
Illness 52.28 11.17 86 76254 9191 31611813
Rheumatoid arthritis 50.51 11.17 26 76314 47783 31573221
Educational problem 49.99 11.17 25 76315 520 31620484
Dehydration 49.51 11.17 136 76204 118975 31502029
Disease progression 49.30 11.17 89 76251 90375 31530629
Septic shock 49.18 11.17 52 76288 66106 31554898
Dyspnoea at rest 48.87 11.17 51 76289 3480 31617524
Blood pressure increased 47.76 11.17 342 75998 79291 31541713
Discomfort 47.64 11.17 115 76225 16241 31604763
Anaphylactic reaction 47.52 11.17 168 76172 29385 31591619
Renal impairment 47.01 11.17 85 76255 86264 31534740
Suffocation feeling 46.98 11.17 24 76316 523 31620481
Platelet count decreased 46.72 11.17 125 76215 110310 31510694
Product quality issue 46.63 11.17 113 76227 15998 31605006
Eye disorder 45.49 11.17 77 76263 8425 31612579
Gastrointestinal haemorrhage 45.17 11.17 81 76259 82468 31538536
Foetal exposure during pregnancy 45.04 11.17 21 76319 40855 31580149
Obesity 44.80 11.17 89 76251 11011 31609993
Blood pressure systolic increased 44.49 11.17 125 76215 19345 31601659
Panic attack 44.17 11.17 77 76263 8626 31612378
Chronic sinusitis 44.04 11.17 36 76304 1793 31619211
Personality change 43.98 11.17 56 76284 4739 31616265
Oropharyngeal pain 43.14 11.17 170 76170 31313 31589691
Eosinophil count 43.02 11.17 15 76325 118 31620886
Dust allergy 42.50 11.17 23 76317 566 31620438
Pruritus 42.18 11.17 474 75866 124693 31496311
Food allergy 41.26 11.17 28 76312 1047 31619957
Forced vital capacity decreased 40.99 11.17 24 76316 690 31620314
Rhinitis allergic 40.90 11.17 42 76298 2812 31618192
Ascites 40.86 11.17 24 76316 40989 31580015
Negative thoughts 40.74 11.17 23 76317 616 31620388
Aortic valve stenosis 40.61 11.17 39 76301 2407 31618597
Hypoventilation 40.06 11.17 43 76297 3031 31617973
Respiratory disorder 40.00 11.17 114 76226 17786 31603218
Eye swelling 39.99 11.17 76 76264 9100 31611904
Anosmia 39.60 11.17 36 76304 2072 31618932
Eczema 39.25 11.17 103 76237 15314 31605690
Cardiac arrest 39.04 11.17 99 76241 88963 31532041
Emotional disorder 38.52 11.17 55 76285 5194 31615810
Bone marrow failure 38.39 11.17 10 76330 27998 31593006
Hyperkalaemia 38.10 11.17 60 76280 64291 31556713
Chest X-ray abnormal 38.04 11.17 48 76292 4025 31616979
Body temperature decreased 37.81 11.17 86 76254 11684 31609320
General physical health deterioration 37.74 11.17 143 76197 113292 31507712
Restrictive pulmonary disease 37.66 11.17 27 76313 1104 31619900
Nasal inflammation 37.65 11.17 16 76324 225 31620779
Ocular discomfort 37.04 11.17 33 76307 1850 31619154
Sinus congestion 36.26 11.17 52 76288 4931 31616073
Peak expiratory flow rate decreased 35.28 11.17 13 76327 122 31620882
Perfume sensitivity 35.14 11.17 12 76328 88 31620916
Smoke sensitivity 35.00 11.17 13 76327 125 31620879
Respiratory tract infection 34.64 11.17 107 76233 17454 31603550
Myocardial infarction 34.60 11.17 148 76192 113306 31507698
Cardio-respiratory arrest 33.80 11.17 45 76295 51681 31569323
Intentional overdose 33.69 11.17 30 76310 41359 31579645
Respiratory rate increased 33.62 11.17 71 76269 9174 31611830
Coma 33.29 11.17 30 76310 41120 31579884
Cardiac failure 32.89 11.17 102 76238 85851 31535153
Nasal oedema 32.88 11.17 16 76324 313 31620691
Drug resistance 32.86 11.17 8 76332 23445 31597559
Hypokalaemia 32.63 11.17 49 76291 53525 31567479
Product use in unapproved indication 31.79 11.17 372 75968 98799 31522205
Morbid thoughts 31.77 11.17 14 76326 216 31620788
Reversible airways obstruction 31.56 11.17 16 76324 343 31620661
Pleural effusion 31.52 11.17 85 76255 74835 31546169
Sputum purulent 31.28 11.17 17 76323 422 31620582
Status asthmaticus 31.03 11.17 15 76325 289 31620715
Acute myocardial infarction 30.45 11.17 47 76293 50776 31570228
Lung hyperinflation 29.85 11.17 21 76319 833 31620171
Throat clearing 29.72 11.17 14 76326 254 31620750
Blood test abnormal 29.45 11.17 53 76287 6088 31614916
Malaise 29.29 11.17 569 75771 167942 31453062
Pneumonia 29.23 11.17 1033 75307 334279 31286725
C-reactive protein increased 29.14 11.17 45 76295 48605 31572399
Oesophageal polyp 28.63 11.17 9 76331 49 31620955
Sinus polyp 28.61 11.17 12 76328 163 31620841
Adjustment disorder 28.49 11.17 23 76317 1125 31619879
Agranulocytosis 28.34 11.17 8 76332 21239 31599765
Delirium 28.13 11.17 35 76305 41386 31579618
International normalised ratio increased 27.89 11.17 41 76299 45182 31575822
Eosinophilic bronchitis 27.84 11.17 12 76328 175 31620829
Total lung capacity abnormal 27.67 11.17 11 76329 129 31620875
Pleural thickening 27.62 11.17 14 76326 300 31620704
Nausea 27.47 11.17 550 75790 307397 31313607
Stress 27.44 11.17 126 76214 24815 31596189
Neuroleptic malignant syndrome 27.36 11.17 4 76336 16865 31604139
Sinus disorder 27.26 11.17 52 76288 6243 31614761
Forced expiratory volume abnormal 27.26 11.17 8 76332 33 31620971
Nasal discharge discolouration 27.25 11.17 13 76327 243 31620761
Blebitis 27.13 11.17 6 76334 4 31621000
Cardiogenic shock 27.12 11.17 10 76330 22398 31598606
Attention deficit hyperactivity disorder 26.87 11.17 31 76309 2367 31618637
Throat tightness 26.85 11.17 58 76282 7611 31613393
Diastolic dysfunction 26.81 11.17 47 76293 5288 31615716
Mucosal inflammation 26.78 11.17 26 76314 34401 31586603
Epidural lipomatosis 26.76 11.17 19 76321 765 31620239
Cytomegalovirus infection 26.74 11.17 13 76327 24694 31596310
Bradycardia 26.71 11.17 82 76258 69245 31551759
Intervertebral disc degeneration 26.61 11.17 48 76292 5523 31615481
Endocarditis fibroplastica 26.56 11.17 6 76334 5 31620999
Homicidal ideation 26.56 11.17 32 76308 2559 31618445
Metabolic acidosis 26.29 11.17 34 76306 39543 31581461
Hepatic failure 26.26 11.17 24 76316 32678 31588326
Hypereosinophilic syndrome 26.18 11.17 12 76328 204 31620800
Attention-seeking behaviour 26.18 11.17 8 76332 39 31620965
Excessive eye blinking 26.16 11.17 16 76324 499 31620505
Snoring 26.04 11.17 34 76306 2949 31618055
Syncope 26.03 11.17 111 76229 85071 31535933
Suicidal behaviour 26.01 11.17 24 76316 1408 31619596
Electrocardiogram QT prolonged 25.90 11.17 32 76308 37955 31583049
Haematemesis 25.56 11.17 15 76325 25638 31595366
Throat irritation 25.54 11.17 64 76276 9250 31611754
Cerebral haemorrhage 25.27 11.17 25 76315 32787 31588217
Product substitution issue 25.02 11.17 64 76276 9368 31611636
Panic reaction 24.93 11.17 23 76317 1349 31619655
Cystic fibrosis 24.74 11.17 27 76313 1939 31619065
Pigment dispersion syndrome 24.71 11.17 6 76334 9 31620995
Sleep talking 24.63 11.17 15 76325 464 31620540
Neoplasm progression 24.62 11.17 9 76331 20263 31600741
Blood immunoglobulin G decreased 24.39 11.17 22 76318 1253 31619751
Polyp 24.39 11.17 35 76305 3321 31617683
Asthenia 24.26 11.17 388 75952 224367 31396637
Enuresis 24.08 11.17 28 76312 2156 31618848
Contraindicated product administered 23.64 11.17 9 76331 19763 31601241
Blood lactic acid 23.55 11.17 13 76327 333 31620671
Asthma exercise induced 23.40 11.17 9 76331 96 31620908
Constipation 23.25 11.17 189 76151 123802 31497202
Melaena 22.80 11.17 27 76313 32627 31588377
Fear 22.75 11.17 64 76276 9910 31611094
Lactic acidosis 22.73 11.17 26 76314 31911 31589093
Nasal discomfort 22.68 11.17 23 76317 1517 31619487
Encephalopathy 22.51 11.17 27 76313 32447 31588557
Hyperkaliuria 22.31 11.17 9 76331 110 31620894
Palmar-plantar erythrodysaesthesia syndrome 22.25 11.17 5 76335 15478 31605526
Meningitis eosinophilic 22.17 11.17 6 76334 17 31620987
Self-injurious ideation 22.10 11.17 23 76317 1564 31619440
Hypoglycaemia 22.03 11.17 57 76283 50889 31570115
White blood cell count decreased 22 11.17 122 76218 87276 31533728
Chronic spontaneous urticaria 21.93 11.17 10 76330 168 31620836
Bronchiolitis obliterans syndrome 21.93 11.17 10 76330 168 31620836
Allergic respiratory disease 21.84 11.17 7 76333 41 31620963
Lower respiratory tract congestion 21.82 11.17 19 76321 1033 31619971
NPM1 gene mutation 21.81 11.17 9 76331 117 31620887
Tearfulness 21.74 11.17 25 76315 1902 31619102
Blood bilirubin increased 21.52 11.17 32 76308 35104 31585900
Acute myeloid leukaemia 21.50 11.17 9 76331 18663 31602341
Gastroenteritis viral 21.44 11.17 47 76293 6230 31614774
Stomatitis 21.29 11.17 39 76301 39399 31581605
Mite allergy 21.12 11.17 13 76327 410 31620594
Temperature intolerance 21.07 11.17 31 76309 3008 31617996
Neuropsychiatric symptoms 20.95 11.17 14 76326 510 31620494
Hyperglycaemia 20.66 11.17 35 76305 36441 31584563
Dysphonia 20.45 11.17 101 76239 20490 31600514
Rhonchi 20.30 11.17 23 76317 1722 31619282
Respiratory symptom 20.14 11.17 20 76320 1286 31619718
Hypohidrosis 20.08 11.17 10 76330 206 31620798
Urinary tract infection 20.06 11.17 106 76234 76763 31544241
Alanine aminotransferase increased 20.02 11.17 102 76238 74554 31546450
Child abuse 19.95 11.17 12 76328 363 31620641
Sputum abnormal 19.89 11.17 13 76327 456 31620548
Respiratory tract irritation 19.74 11.17 9 76331 151 31620853
Stiff person syndrome 19.67 11.17 8 76332 100 31620904
Abnormal dreams 19.66 11.17 49 76291 7059 31613945
Tubulointerstitial nephritis 19.61 11.17 10 76330 18486 31602518
Mononeuropathy multiplex 19.58 11.17 9 76331 154 31620850
Lung hernia 19.35 11.17 7 76333 62 31620942
Status epilepticus 19.34 11.17 3 76337 12103 31608901
Airway remodelling 19.22 11.17 9 76331 161 31620843
Obsessive-compulsive disorder 19.22 11.17 39 76301 4898 31616106
Secretion discharge 19.22 11.17 39 76301 4898 31616106
Blood urea increased 19.19 11.17 25 76315 28987 31592017
Pneumocystis jirovecii pneumonia 19.16 11.17 10 76330 18241 31602763
Haematuria 19.13 11.17 53 76287 46261 31574743
Physical assault 19.11 11.17 18 76322 1084 31619920
Nocturnal dyspnoea 19.11 11.17 13 76327 488 31620516
Sedation 19.02 11.17 11 76329 18954 31602050
Forced expiratory flow decreased 19.02 11.17 9 76331 165 31620839
Bronchitis viral 18.97 11.17 10 76330 233 31620771
Scleroderma 18.90 11.17 20 76320 1387 31619617
Decreased appetite 18.76 11.17 258 76082 152959 31468045
Self esteem decreased 18.74 11.17 13 76327 504 31620500
Nasal septum deviation 18.62 11.17 17 76323 984 31620020
Diaphragmatic disorder 18.58 11.17 18 76322 1123 31619881
Acute respiratory distress syndrome 18.55 11.17 19 76321 24521 31596483
Upper respiratory tract congestion 18.42 11.17 15 76325 743 31620261
Cerebrovascular accident 18.38 11.17 114 76226 79370 31541634
Pyrexia 18.30 11.17 575 75765 303265 31317739
Hepatocellular injury 18.28 11.17 15 76325 21529 31599475
Mast cell activation syndrome 18.22 11.17 9 76331 182 31620822
Somnambulism 18.22 11.17 28 76312 2824 31618180
Migraine 18.16 11.17 75 76265 14105 31606899
Sopor 18.14 11.17 3 76337 11549 31609455
Vomiting 17.61 11.17 408 75932 223565 31397439
Mental disorder 17.59 11.17 73 76267 13761 31607243
Fall 17.57 11.17 329 76011 185760 31435244
Hyperbilirubinaemia 17.49 11.17 8 76332 15742 31605262
Altered state of consciousness 17.44 11.17 15 76325 21036 31599968
Benign prostatic hyperplasia 17.27 11.17 70 76270 13055 31607949
Angina pectoris 17.19 11.17 28 76312 29613 31591391
Weight increased 17.17 11.17 288 76052 82659 31538345
Steroid diabetes 17.12 11.17 22 76318 1878 31619126
Bone density decreased 17.09 11.17 21 76319 1714 31619290
Neutrophil count decreased 17.07 11.17 56 76284 46338 31574666
Cortisol decreased 16.91 11.17 16 76324 969 31620035
Depressed level of consciousness 16.83 11.17 43 76297 38558 31582446
Poor quality device used 16.73 11.17 15 76325 848 31620156
Alopecia areata 16.68 11.17 9 76331 220 31620784
Treatment failure 16.61 11.17 47 76293 40745 31580259
Disseminated intravascular coagulation 16.57 11.17 15 76325 20522 31600482
Total lung capacity decreased 16.50 11.17 13 76327 614 31620390
Oedema peripheral 16.46 11.17 177 76163 109662 31511342
Unresponsive to stimuli 16.29 11.17 23 76317 25777 31595227
Haematochezia 16.20 11.17 47 76293 40417 31580587
Chimerism 16.18 11.17 9 76331 234 31620770
Pulmonary oedema 16.18 11.17 54 76286 44448 31576556
Feeling abnormal 16.16 11.17 209 76131 56793 31564211
Growth retardation 15.99 11.17 20 76320 1662 31619342
Agitation 15.94 11.17 200 76140 53969 31567035
Intentional product use issue 15.88 11.17 63 76277 49284 31571720
Nasal mucosal disorder 15.77 11.17 7 76333 110 31620894
Sputum retention 15.75 11.17 11 76329 431 31620573
Prostatomegaly 15.73 11.17 36 76304 4911 31616093
Hypercalcaemia 15.72 11.17 7 76333 13993 31607011
Glaucoma 15.60 11.17 42 76298 6338 31614666
Aspartate aminotransferase increased 15.53 11.17 88 76252 62631 31558373
Small airways disease 15.50 11.17 5 76335 30 31620974
Hostility 15.44 11.17 14 76326 803 31620201
Behaviour disorder 15.36 11.17 33 76307 4314 31616690
Eosinophilic oesophagitis 15.30 11.17 9 76331 261 31620743
Plasma cell myeloma 15.29 11.17 77 76263 56454 31564550
Hypomagnesaemia 15.28 11.17 14 76326 19044 31601960
Circulatory collapse 15.25 11.17 15 76325 19729 31601275
Peritonitis 15.22 11.17 9 76331 15318 31605686
Shock haemorrhagic 15.21 11.17 3 76337 10174 31610830
Subdural haematoma 15.14 11.17 14 76326 18957 31602047
Bronchiolitis 15.14 11.17 26 76314 2878 31618126
Affective disorder 15.13 11.17 30 76310 3706 31617298
ACTH stimulation test abnormal 15.09 11.17 3 76337 0 31621004
Pigmentary glaucoma 15.09 11.17 3 76337 0 31621004
Cephalo-pelvic disproportion 15.09 11.17 3 76337 0 31621004
Exophthalmos congenital 15.09 11.17 3 76337 0 31621004
Seizure anoxic 15.09 11.17 3 76337 0 31621004
Hepatic encephalopathy 15.09 11.17 7 76333 13664 31607340
Lung disorder 15.06 11.17 131 76209 32181 31588823
Spirometry abnormal 15.04 11.17 11 76329 464 31620540
Bronchopulmonary aspergillosis 15.02 11.17 7 76333 13627 31607377
Oropharyngeal discomfort 14.96 11.17 25 76315 2706 31618298
Vasculitis 14.95 11.17 50 76290 8500 31612504
Drug level increased 14.84 11.17 16 76324 20170 31600834
Frustration tolerance decreased 14.78 11.17 23 76317 2345 31618659
Hospitalisation 14.70 11.17 184 76156 49623 31571381
Extrapyramidal disorder 14.69 11.17 5 76335 11773 31609231
Allergy to plants 14.61 11.17 4 76336 12 31620992
Haemophilus infection 14.57 11.17 15 76325 1007 31619997
Central obesity 14.52 11.17 11 76329 490 31620514
Ocular hyperaemia 14.48 11.17 55 76285 9954 31611050
Hemiparesis 14.43 11.17 9 76331 14885 31606119
Clostridium difficile colitis 14.32 11.17 8 76332 14048 31606956
Device related infection 14.27 11.17 11 76329 16288 31604716
Hepatotoxicity 14.24 11.17 15 76325 19111 31601893
Renal tubular necrosis 14.19 11.17 9 76331 14750 31606254
Diabetic ketoacidosis 14.06 11.17 12 76328 16893 31604111
Idiopathic intracranial hypertension 14.01 11.17 12 76328 638 31620366
Human ehrlichiosis 13.98 11.17 8 76332 220 31620784
Juvenile idiopathic arthritis 13.97 11.17 19 76321 1714 31619290
Actinic keratosis 13.94 11.17 31 76309 4148 31616856
Disturbance in social behaviour 13.72 11.17 19 76321 1744 31619260
Cytokine release syndrome 13.61 11.17 12 76328 16630 31604374
Deep vein thrombosis 13.58 11.17 88 76252 60648 31560356
Swelling face 13.46 11.17 93 76247 21297 31599707
Injection site swelling 13.43 11.17 54 76286 10033 31610971
Lymphopenia 13.42 11.17 9 76331 14320 31606684
Injection site pruritus 13.40 11.17 39 76301 6155 31614849
Metastases to liver 13.32 11.17 7 76333 12720 31608284
Dysphagia 13.19 11.17 83 76257 57593 31563411
Hand-foot-and-mouth disease 13.11 11.17 5 76335 52 31620952
COVID-19 13.10 11.17 195 76145 54626 31566378
Respiration abnormal 13.08 11.17 24 76316 2798 31618206
Atopy 13.05 11.17 7 76333 169 31620835
Conjunctivitis 12.99 11.17 48 76292 8575 31612429
Ischaemic stroke 12.99 11.17 13 76327 16958 31604046
Choking 12.97 11.17 32 76308 4580 31616424
Kidney infection 12.96 11.17 33 76307 4817 31616187
Prolonged expiration 12.94 11.17 7 76333 172 31620832
Mycobacterial infection 12.92 11.17 21 76319 2222 31618782
Facial discomfort 12.85 11.17 4 76336 21 31620983
Haematocrit decreased 12.71 11.17 34 76306 30027 31590977
Hallucination, auditory 12.65 11.17 54 76286 10306 31610698
Shock 12.57 11.17 22 76318 22623 31598381
Separation anxiety disorder 12.56 11.17 3 76337 4 31621000
Anuria 12.53 11.17 4 76336 9810 31611194
Chronic kidney disease 12.53 11.17 48 76292 37927 31583077
Duodenal ulcer 12.43 11.17 4 76336 9760 31611244
Eosinophil count abnormal 12.41 11.17 8 76332 274 31620730
Coronary artery disease 12.33 11.17 63 76277 46024 31574980
Myelodysplastic syndrome 12.31 11.17 17 76323 19234 31601770
Disease prodromal stage 12.26 11.17 4 76336 25 31620979
Electrolyte imbalance 12.25 11.17 7 76333 12141 31608863
Hepatocellular carcinoma 12.24 11.17 3 76337 8753 31612251
Interstitial lung disease 12.24 11.17 92 76248 61311 31559693
Dysarthria 12.23 11.17 38 76302 31979 31589025
Stridor 12.22 11.17 21 76319 2326 31618678
Dermatitis allergic 12.21 11.17 37 76303 5972 31615032
Eye irritation 12.19 11.17 39 76301 6479 31614525
Onychophagia 12.19 11.17 5 76335 64 31620940
Fight in school 12.16 11.17 3 76337 5 31620999
Tachycardia 12.15 11.17 121 76219 76086 31544918
Acute hepatic failure 12.15 11.17 8 76332 12851 31608153
Sinus bradycardia 12.14 11.17 7 76333 12080 31608924
Rhinalgia 12.10 11.17 9 76331 390 31620614
Hyposmia 12.02 11.17 7 76333 199 31620805
Graft versus host disease in lung 12.01 11.17 10 76330 511 31620493
Product taste abnormal 11.95 11.17 14 76326 1087 31619917
Quality of life decreased 11.95 11.17 26 76314 3429 31617575
Haemodynamic instability 11.87 11.17 3 76337 8572 31612432
Atrioventricular block complete 11.85 11.17 3 76337 8562 31612442
Liver function test decreased 11.78 11.17 5 76335 70 31620934
Subarachnoid haemorrhage 11.75 11.17 5 76335 10266 31610738
Gastrointestinal tract mucosal pigmentation 11.72 11.17 9 76331 409 31620595
Posterior reversible encephalopathy syndrome 11.64 11.17 4 76336 9363 31611641
Metastases to lung 11.55 11.17 3 76337 8419 31612585
Myoclonus 11.55 11.17 10 76330 13980 31607024
Proteinuria 11.55 11.17 14 76326 16749 31604255
Liver disorder 11.53 11.17 35 76305 29672 31591332
Premature baby 11.51 11.17 16 76324 18050 31602954
Breath holding 11.50 11.17 3 76337 7 31620997
Occupational exposure to dust 11.50 11.17 3 76337 7 31620997
Episcleritis 11.49 11.17 6 76334 137 31620867
Social problem 11.45 11.17 12 76328 823 31620181
Blood creatine phosphokinase increased 11.44 11.17 57 76283 41917 31579087
Breech presentation 11.41 11.17 6 76334 139 31620865
Pain 11.32 11.17 353 75987 186406 31434598
Cerebral infarction 11.27 11.17 29 76311 25948 31595056
Schizophrenia 11.27 11.17 6 76334 10824 31610180
Hepatic cytolysis 11.26 11.17 6 76334 10817 31610187
Bronchial disorder 11.20 11.17 15 76325 1334 31619670
Airway complication of anaesthesia 11.18 11.17 6 76334 145 31620859

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Asthma 7827.75 10.14 4737 208978 116056 70598673
Wheezing 2612.69 10.14 2207 211508 91963 70622766
Eosinophilic granulomatosis with polyangiitis 1751.20 10.14 567 213148 2646 70712083
Obstructive airways disorder 1354.06 10.14 892 212823 25221 70689508
Cough 1099.19 10.14 2774 210941 322603 70392126
Dyspnoea 902.38 10.14 4631 209084 765429 69949300
Productive cough 886.91 10.14 1136 212579 77201 70637528
Forced expiratory volume decreased 875.92 10.14 432 213283 6882 70707847
Full blood count abnormal 830.89 10.14 741 212974 33137 70681592
Sputum discoloured 815.78 10.14 576 213139 18275 70696454
Toxicity to various agents 621.35 10.14 190 213525 381982 70332747
Sleep disorder due to a general medical condition 604.81 10.14 383 213332 10093 70704636
Chest discomfort 603.52 10.14 1226 212489 123155 70591574
Sleep terror 493.89 10.14 172 213543 1043 70713686
Nasal congestion 478.97 10.14 773 212942 64899 70649830
Nightmare 466.26 10.14 445 213270 21711 70693018
Urticaria 460.78 10.14 1303 212412 161746 70552983
Middle insomnia 410.82 10.14 340 213375 13713 70701016
Blood immunoglobulin E increased 357.99 10.14 206 213509 4538 70710191
Acute kidney injury 356.35 10.14 550 213165 474074 70240655
Nasal polyps 340.52 10.14 196 213519 4320 70710409
Sinusitis 336.47 10.14 1198 212517 167997 70546732
Bronchitis 326.20 10.14 932 212783 116311 70598418
Suicidal ideation 321.97 10.14 673 213042 68923 70645806
Gastrooesophageal reflux disease 314.31 10.14 783 212932 90056 70624673
Chronic obstructive pulmonary disease 313.83 10.14 711 213004 76930 70637799
Food allergy 311.01 10.14 235 213480 8289 70706440
Abnormal behaviour 307.16 10.14 447 213268 34262 70680467
Therapeutic product effect incomplete 294.59 10.14 912 212803 118970 70595759
Off label use 291.81 10.14 1202 212513 741858 69972871
Rhinitis allergic 290.86 10.14 234 213481 9061 70705668
Synovitis 287.98 10.14 28 213687 129200 70585529
Aggression 286.91 10.14 520 213195 47926 70666803
Drug interaction 269.22 10.14 460 213255 380981 70333748
Anaemia 263.77 10.14 510 213205 402913 70311816
Seasonal allergy 263.36 10.14 260 213455 13224 70701505
Neutropenia 258.96 10.14 236 213479 256920 70457809
Asthmatic crisis 254.90 10.14 121 213594 1763 70712966
Influenza 252.95 10.14 836 212879 112864 70601865
Upper respiratory tract infection 243.99 10.14 654 213061 78620 70636109
Completed suicide 243.86 10.14 196 213519 226939 70487790
Dyspnoea exertional 228.37 10.14 634 213081 77796 70636933
Pemphigus 225.77 10.14 5 213710 83031 70631698
Hand deformity 224.86 10.14 8 213707 86474 70628255
Anger 223.03 10.14 259 213456 15873 70698856
Breath sounds abnormal 221.86 10.14 235 213480 12996 70701733
Eosinophil count increased 219.90 10.14 250 213465 14972 70699757
Thrombocytopenia 218.29 10.14 239 213476 238871 70475858
Drug abuse 216.89 10.14 86 213629 147170 70567559
Anxiety 215.96 10.14 1266 212449 219064 70495665
Sleep apnoea syndrome 215.52 10.14 368 213347 32345 70682384
Pancytopenia 214.89 10.14 93 213622 151014 70563715
Febrile neutropenia 213.50 10.14 181 213534 204137 70510592
Rheumatoid arthritis 213.10 10.14 344 213371 291461 70423268
Loss of personal independence in daily activities 208.55 10.14 646 213069 84264 70630465
Temperature regulation disorder 206.73 10.14 142 213573 4302 70710427
Infective pulmonary exacerbation of cystic fibrosis 203.96 10.14 216 213499 11942 70702787
Impaired quality of life 198.89 10.14 185 213530 8731 70705998
Rhinorrhoea 197.65 10.14 541 213174 65830 70648899
Upper-airway cough syndrome 196.31 10.14 191 213524 9540 70705189
Treatment failure 192.17 10.14 97 213618 144045 70570684
Headache 189.29 10.14 2619 211096 577786 70136943
Hypotension 185.20 10.14 613 213102 403768 70310961
Malignant neoplasm progression 184.42 10.14 68 213647 121671 70593058
Eosinophilia 181.88 10.14 386 213329 39933 70674796
Polycystic ovaries 178.35 10.14 110 213605 2762 70711967
Death 176.33 10.14 864 212851 509197 70205532
Bronchial secretion retention 173.61 10.14 110 213605 2900 70711829
Anaphylactic reaction 170.02 10.14 555 213160 74419 70640310
Bronchospasm 169.78 10.14 271 213444 22521 70692208
Blood test abnormal 165.56 10.14 212 213503 14378 70700351
Pericarditis 165.47 10.14 28 213687 84677 70630052
Respiratory tract congestion 162.97 10.14 232 213483 17421 70697308
Rhinitis 160.65 10.14 186 213529 11361 70703368
Product quality issue 159.71 10.14 311 213404 30250 70684479
Product dose omission issue 157.82 10.14 1159 212556 216309 70498420
Respiratory tract infection 157.79 10.14 376 213339 42022 70672707
Joint swelling 157.66 10.14 329 213386 252882 70461847
Hyponatraemia 157.41 10.14 150 213565 159937 70554792
Pulmonary function test decreased 157.30 10.14 144 213571 6657 70708072
Pulmonary function test abnormal 155.93 10.14 108 213607 3317 70711412
Multiple organ dysfunction syndrome 152.34 10.14 68 213647 108447 70606282
Arthropathy 150.60 10.14 138 213577 149919 70564810
Nasopharyngitis 149.29 10.14 1163 212552 221043 70493686
Coeliac disease 148.90 10.14 159 213556 8874 70705855
Mood altered 148.39 10.14 214 213501 16261 70698468
Crying 148.31 10.14 245 213470 20954 70693775
Drug intolerance 146.67 10.14 286 213429 225401 70489328
Systemic lupus erythematosus 145.99 10.14 62 213653 101840 70612889
Heart rate increased 144.83 10.14 669 213046 105479 70609250
Sensitivity to weather change 143.15 10.14 142 213573 7263 70707466
Contraindicated product administered 142.10 10.14 118 213597 134494 70580235
Glossodynia 142.04 10.14 42 213673 86445 70628284
Pneumonia 140.98 10.14 2550 211165 593682 70121047
Oropharyngeal pain 137.35 10.14 615 213100 95695 70619034
Asthma-chronic obstructive pulmonary disease overlap syndrome 137.27 10.14 75 213640 1489 70713240
Sensitisation 136.73 10.14 88 213627 2385 70712344
Bronchiectasis 136.17 10.14 203 213512 15894 70698835
Depression 135.07 10.14 1044 212671 197930 70516799
General physical health deterioration 130.46 10.14 327 213388 235704 70479025
Secretion discharge 129.88 10.14 177 213538 12756 70701973
Stomatitis 127.98 10.14 119 213596 128392 70586337
Renal impairment 127.85 10.14 147 213568 143790 70570939
Sputum increased 126.31 10.14 102 213613 3970 70710759
Chronic spontaneous urticaria 125.26 10.14 63 213652 1048 70713681
Vital capacity decreased 124.86 10.14 68 213647 1341 70713388
Pruritus 124.62 10.14 1589 212126 343971 70370758
Disease progression 123.62 10.14 175 213540 156497 70558232
Helicobacter infection 121.51 10.14 13 213702 55643 70659086
Infusion related reaction 120.95 10.14 259 213456 197275 70517454
Blood pressure systolic increased 120.17 10.14 413 213302 56846 70657883
Dermatitis atopic 120.16 10.14 142 213573 8865 70705864
Therapeutic product effect decreased 119.68 10.14 153 213562 142865 70571864
Illness 119.44 10.14 283 213432 31508 70683221
Confusional state 119.41 10.14 447 213268 283951 70430778
Sneezing 118.71 10.14 196 213519 16755 70697974
Perfume sensitivity 116.41 10.14 53 213662 698 70714031
Peak expiratory flow rate decreased 116.24 10.14 51 213664 612 70714117
Multiple allergies 114.72 10.14 129 213586 7631 70707098
Bronchial wall thickening 114.25 10.14 75 213640 2104 70712625
Forced vital capacity decreased 113.81 10.14 67 213648 1542 70713187
Leukopenia 111.73 10.14 94 213621 106466 70608263
Septic shock 111.72 10.14 104 213611 112154 70602575
Eye pruritus 111.63 10.14 176 213539 14471 70700258
Eczema 111.34 10.14 286 213429 33495 70681234
Bronchial obstruction 111.03 10.14 78 213637 2452 70712277
Sepsis 109.53 10.14 374 213341 244171 70470558
Intentional overdose 109.28 10.14 82 213633 98353 70616376
Respiratory rate increased 108.70 10.14 205 213510 19467 70695262
Throat clearing 107.44 10.14 66 213649 1645 70713084
Dust allergy 107.31 10.14 58 213657 1126 70713603
Diarrhoea 105.45 10.14 1694 212021 781647 69933082
Haemoglobin decreased 105.18 10.14 295 213420 204864 70509865
C-reactive protein increased 104.64 10.14 107 213608 110410 70604319
Reversible airways obstruction 103.50 10.14 63 213652 1544 70713185
Rhabdomyolysis 103.47 10.14 82 213633 95678 70619051
Irritability 103.41 10.14 301 213414 37924 70676805
Insomnia 102.95 10.14 1056 212659 216750 70497979
Ejection fraction 100.64 10.14 64 213651 1698 70713031
Dysphonia 100.48 10.14 356 213359 49744 70664985
Coma 98.79 10.14 79 213636 91765 70622964
Intentional product use issue 97.97 10.14 131 213584 120011 70594718
Platelet count decreased 97.60 10.14 248 213467 177974 70536755
Lung hyperinflation 97.03 10.14 62 213653 1659 70713070
Blood creatinine increased 96.56 10.14 177 213538 142824 70571905
Bone marrow failure 96.15 10.14 16 213699 48994 70665735
Total lung capacity increased 96.13 10.14 50 213665 895 70713834
Muscle injury 95.30 10.14 5 213710 38489 70676240
Status asthmaticus 95.29 10.14 51 213664 970 70713759
Aspirin-exacerbated respiratory disease 95.00 10.14 54 213661 1161 70713568
Mucosal inflammation 94.46 10.14 43 213672 67807 70646922
Sinus congestion 93.46 10.14 179 213536 17194 70697535
Chronic sinusitis 91.51 10.14 120 213595 8331 70706398
Blood pressure increased 91.47 10.14 919 212796 187598 70527131
Nasal oedema 91.33 10.14 54 213661 1253 70713476
Hyperkalaemia 91.28 10.14 112 213603 106479 70608250
Allergy to animal 91.27 10.14 52 213663 1123 70713606
Malaise 90.89 10.14 1819 211896 431113 70283616
Mood swings 90.61 10.14 182 213533 18104 70696625
Hypoventilation 88.19 10.14 104 213611 6478 70708251
Impaired healing 87.77 10.14 58 213657 74316 70640413
Bronchopulmonary aspergillosis allergic 87.09 10.14 61 213654 1908 70712821
Rales 86.65 10.14 172 213543 16963 70697766
Metabolic acidosis 86.36 10.14 59 213656 74287 70640442
Bronchial hyperreactivity 86.19 10.14 68 213647 2558 70712171
Folliculitis 85.54 10.14 13 213702 42557 70672172
Wound 85.33 10.14 103 213612 98629 70616100
Restrictive pulmonary disease 85.06 10.14 64 213651 2242 70712487
Hypersensitivity 84.96 10.14 1062 212653 228750 70485979
Respiratory disorder 84.55 10.14 285 213430 38838 70675891
Bradycardia 84.34 10.14 154 213561 124461 70590268
Renal failure 84.06 10.14 290 213425 188780 70525949
Poor quality device used 83.61 10.14 61 213654 2037 70712692
Respiratory symptom 83.46 10.14 78 213637 3703 70711026
Vocal cord dysfunction 82.49 10.14 36 213679 426 70714303
Cardiac failure 82.30 10.14 195 213520 143346 70571383
C-reactive protein abnormal 81.74 10.14 10 213705 38569 70676160
Sinus disorder 81.46 10.14 178 213537 18781 70695948
Immunodeficiency 81.40 10.14 170 213545 17385 70697344
Cardiac arrest 81.03 10.14 231 213484 159603 70555126
Hypokalaemia 79.45 10.14 173 213542 131015 70583714
Ascites 79.27 10.14 53 213662 67494 70647235
Cardio-respiratory arrest 78.85 10.14 113 213602 100564 70614165
Respiration abnormal 78.29 10.14 100 213615 6764 70707965
Sleep disorder 77.95 10.14 416 213299 69456 70645273
Right atrial hypertrophy 77.77 10.14 38 213677 592 70714137
Cystic fibrosis 77.08 10.14 79 213636 4202 70710527
Depressed level of consciousness 76.85 10.14 90 213625 87341 70627388
Neurotoxicity 76.69 10.14 3 213712 29823 70684906
Migraine 76.48 10.14 424 213291 71814 70642915
Rhonchi 76.09 10.14 73 213642 3582 70711147
Throat irritation 75.25 10.14 256 213459 35048 70679681
Nasal discharge discolouration 75.09 10.14 57 213658 2024 70712705
Abnormal dreams 74.78 10.14 123 213592 10480 70704249
Lower respiratory tract infection 74.09 10.14 584 213131 111329 70603400
Educational problem 73.83 10.14 32 213683 372 70714357
Gastrointestinal haemorrhage 73.07 10.14 194 213521 137214 70577515
Smoke sensitivity 70.21 10.14 34 213681 519 70714210
Dehydration 69.58 10.14 398 213317 225744 70488985
Throat tightness 69.58 10.14 199 213516 24823 70689906
Rash erythematous 66.87 10.14 321 213394 51397 70663332
Depressed mood 66.38 10.14 285 213430 43535 70671194
Alopecia 64.52 10.14 343 213372 198147 70516582
Feeling abnormal 64.35 10.14 684 213031 141635 70573094
White blood cell count decreased 63.43 10.14 280 213435 169861 70544868
Obstruction 63.41 10.14 66 213649 3575 70711154
Frustration tolerance decreased 62.57 10.14 89 213626 6676 70708053
Eosinophilic pneumonia chronic 62.06 10.14 30 213685 456 70714273
Nasal turbinate hypertrophy 61.22 10.14 32 213683 579 70714150
Neoplasm progression 60.90 10.14 30 213685 45198 70669531
Dysplastic naevus 60.82 10.14 31 213684 531 70714198
Bronchial disorder 60.69 10.14 53 213662 2301 70712428
Cytomegalovirus infection 60.53 10.14 22 213693 39736 70674993
Alanine aminotransferase increased 60.40 10.14 234 213481 147246 70567483
Lactic acidosis 60.36 10.14 64 213651 64960 70649769
Sopor 59.60 10.14 11 213704 31256 70683473
Dyspnoea at rest 59.12 10.14 87 213628 6732 70707997
Anosmia 58.65 10.14 73 213642 4810 70709919
Agranulocytosis 58.54 10.14 24 213691 40274 70674455
Acute myocardial infarction 57.87 10.14 81 213634 72806 70641923
Tic 57.68 10.14 55 213660 2678 70712051
Mast cell activation syndrome 57.53 10.14 31 213684 598 70714131
Encephalopathy 56.89 10.14 61 213654 61600 70653129
Musculoskeletal stiffness 56.40 10.14 241 213474 147519 70567210
Decreased appetite 56.17 10.14 617 213098 304163 70410566
Rhinitis perennial 55.68 10.14 25 213690 318 70714411
Idiopathic intracranial hypertension 55.55 10.14 55 213660 2806 70711923
Hepatic failure 55.44 10.14 55 213660 57570 70657159
Ear infection 54.80 10.14 199 213516 28137 70686592
Maternal exposure during pregnancy 54.63 10.14 172 213543 115173 70599556
Hepatocellular injury 54.30 10.14 36 213679 46055 70668674
Total lung capacity decreased 54.15 10.14 46 213669 1923 70712806
Sinusitis fungal 53.87 10.14 47 213668 2038 70712691
Bronchial neoplasm 53.69 10.14 27 213688 449 70714280
Emphysema 53.28 10.14 131 213584 14929 70699800
Acute myeloid leukaemia 52.70 10.14 14 213701 30926 70683803
Delirium 52.47 10.14 90 213625 74524 70640205
Sleep disorder due to general medical condition, insomnia type 52.36 10.14 21 213694 35711 70679018
Bursitis 52.16 10.14 188 213527 26485 70688244
Prolonged expiration 51.63 10.14 34 213681 959 70713770
Nasal inflammation 51.33 10.14 29 213686 616 70714113
Body temperature decreased 50.99 10.14 196 213519 28476 70686253
Serotonin syndrome 50.83 10.14 32 213683 42082 70672647
Screaming 50.83 10.14 59 213656 3613 70711116
Therapy non-responder 50.31 10.14 97 213618 76818 70637911
Psychomotor hyperactivity 50.17 10.14 130 213585 15303 70699426
Neuroleptic malignant syndrome 49.90 10.14 9 213706 25998 70688731
Hyper IgE syndrome 49.71 10.14 26 213689 471 70714258
Hepatotoxicity 49.64 10.14 36 213679 43950 70670779
Hypoglycaemia 49.58 10.14 134 213581 94230 70620499
Palmar-plantar erythrodysaesthesia syndrome 49.09 10.14 15 213700 30232 70684497
Neutropenic sepsis 48.94 10.14 8 213707 24822 70689907
Swelling face 48.82 10.14 342 213373 62822 70651907
Right ventricular hypertrophy 48.80 10.14 38 213677 1402 70713327
Scratch 48.65 10.14 82 213633 7128 70707601
Humidity intolerance 48.58 10.14 23 213692 333 70714396
Victim of child abuse 48.49 10.14 32 213683 906 70713823
Photodermatosis 48.33 10.14 32 213683 911 70713818
Poor quality sleep 48.24 10.14 153 213562 20196 70694533
Angioedema 47.64 10.14 354 213361 66256 70648473
Acute respiratory distress syndrome 47.56 10.14 33 213682 41221 70673508
Nasal obstruction 47.42 10.14 39 213676 1558 70713171
Solar lentigo 47.32 10.14 33 213682 1025 70713704
Blister 46.84 10.14 151 213564 100375 70614354
Blood creatine phosphokinase increased 46.75 10.14 70 213645 61193 70653536
Liver disorder 46.35 10.14 71 213644 61497 70653232
Stress 46.25 10.14 357 213358 67609 70647120
Blood bilirubin increased 46.14 10.14 68 213647 59833 70654896
Aspartate aminotransferase increased 46.10 10.14 211 213504 126767 70587962
Salpingo-oophorectomy unilateral 45.99 10.14 27 213688 618 70714111
Red blood cell sedimentation rate increased 45.77 10.14 30 213685 38612 70676117
Disseminated intravascular coagulation 45.67 10.14 22 213693 33576 70681153
International normalised ratio increased 45.20 10.14 111 213604 80615 70634114
Toxic epidermal necrolysis 45.13 10.14 32 213683 39525 70675204
Drug resistance 44.76 10.14 30 213685 38160 70676569
Skin plaque 44.50 10.14 94 213621 9689 70705040
Mononeuropathy multiplex 44.34 10.14 22 213693 355 70714374
Social avoidant behaviour 44.17 10.14 62 213653 4594 70710135
Hepatic enzyme increased 43.71 10.14 285 213430 156705 70558024
Cholestasis 43.45 10.14 48 213667 47824 70666905
Liver injury 43.24 10.14 36 213679 40999 70673730
Mastocytosis 42.90 10.14 23 213692 439 70714290
Neutrophil count decreased 42.88 10.14 120 213595 83436 70631293
Melaena 42.41 10.14 65 213650 56290 70658439
Pneumonia aspiration 42.11 10.14 77 213638 62212 70652517
Cardiogenic shock 41.91 10.14 29 213686 36278 70678451
Product substitution issue 41.90 10.14 137 213578 18376 70696353
Pulmonary mass 41.51 10.14 172 213543 25861 70688868
Sedation 41.17 10.14 48 213667 46683 70668046
Viral infection 41.07 10.14 226 213489 38165 70676564
Myocardial infarction 40.82 10.14 326 213389 171319 70543410
Metastases to bone 40.31 10.14 9 213706 22367 70692362
Rash maculo-papular 40.29 10.14 56 213659 50489 70664240
Hypomagnesaemia 40.26 10.14 38 213677 40726 70674003
Carpal tunnel syndrome 40.21 10.14 128 213587 16929 70697800
Negative thoughts 40.15 10.14 33 213682 1317 70713412
Circulatory collapse 40.07 10.14 29 213686 35445 70679284
Eye swelling 40.02 10.14 159 213556 23455 70691274
Metastases to liver 39.94 10.14 14 213701 25864 70688865
Pleural effusion 39.68 10.14 236 213479 132628 70582101
Drug level increased 39.67 10.14 31 213684 36438 70678291
Endometrial ablation 39.45 10.14 27 213688 813 70713916
Burning sensation 38.96 10.14 283 213432 52587 70662142
Nasal disorder 38.93 10.14 49 213666 3265 70711464
Aphonia 38.77 10.14 86 213629 9165 70705564
Nervousness 38.68 10.14 191 213524 30929 70683800
Lower respiratory tract congestion 38.58 10.14 49 213666 3295 70711434
Atopy 38.38 10.14 19 213696 305 70714424
Lacrimation increased 37.85 10.14 139 213576 19760 70694969
Eosinophil count 37.78 10.14 14 213701 104 70714625
Nephrectomy 37.51 10.14 36 213679 1767 70712962
Body tinea 37.40 10.14 32 213683 1351 70713378
Anuria 37.28 10.14 7 213708 19646 70695083
Suffocation feeling 37.17 10.14 34 213681 1570 70713159
Ear pruritus 37.04 10.14 46 213669 3024 70711705
Eosinophilic bronchitis 36.74 10.14 20 213695 394 70714335
Abdominal discomfort 36.61 10.14 442 213273 214216 70500513
Colitis 36.31 10.14 87 213628 63727 70651002
Interstitial lung disease 36.21 10.14 177 213538 104508 70610221
Cerebral haemorrhage 36.04 10.14 67 213648 53797 70660932
Haemodynamic instability 35.92 10.14 3 213712 15655 70699074
Skin ulcer 35.78 10.14 56 213659 48089 70666640
Hypereosinophilic syndrome 35.57 10.14 21 213694 486 70714243
Personality change 35.55 10.14 81 213634 8789 70705940
Separation anxiety disorder 35.35 10.14 10 213705 26 70714703
Product use in unapproved indication 35.20 10.14 846 212869 206632 70508097
Haemophagocytic lymphohistiocytosis 35.10 10.14 8 213707 19604 70695125
Pneumocystis jirovecii pneumonia 34.76 10.14 24 213691 30058 70684671
Hepatic function abnormal 34.64 10.14 98 213617 67898 70646831
Lipohypertrophy 34.55 10.14 25 213690 824 70713905
Blood urea increased 34.50 10.14 53 213662 45856 70668873
Diastolic dysfunction 34.38 10.14 83 213632 9350 70705379
Rheumatoid nodule 34.25 10.14 3 213712 15064 70699665
Ear discomfort 34.18 10.14 73 213642 7581 70707148
Affective disorder 34.18 10.14 72 213643 7407 70707322
Biliary dyskinesia 33.97 10.14 39 213676 2360 70712369
Transplant rejection 33.36 10.14 7 213708 18164 70696565
Blood pressure fluctuation 33.14 10.14 81 213634 58931 70655798
Somnambulism 33.10 10.14 58 213657 5202 70709527
Weight decreased 32.96 10.14 1194 212521 309294 70405435
Chest X-ray abnormal 32.91 10.14 69 213646 7075 70707654
Increased viscosity of bronchial secretion 32.86 10.14 20 213695 490 70714239
Blood cholesterol 32.76 10.14 21 213694 565 70714164
Plasma cell myeloma 32.69 10.14 112 213603 73089 70641640
Electrocardiogram QT prolonged 32.61 10.14 135 213580 83382 70631347
Cholecystitis chronic 32.58 10.14 81 213634 9295 70705434
Irritable bowel syndrome 32.50 10.14 65 213650 50785 70663944
Heart sounds 32.49 10.14 23 213692 732 70713997
Temperature intolerance 32.05 10.14 77 213638 8646 70706083
Bone erosion 31.98 10.14 4 213711 15169 70699560
Bronchial haemorrhage 31.61 10.14 28 213687 1239 70713490
Sinus polyp 31.60 10.14 19 213696 455 70714274
Erythema 31.55 10.14 806 212909 198757 70515972
Overdose 31.49 10.14 343 213372 169402 70545327
Creatinine renal clearance decreased 30.82 10.14 7 213708 17193 70697536
Eosinophilic oesophagitis 30.74 10.14 19 213696 479 70714250
Cytokine release syndrome 30.74 10.14 21 213694 26446 70688283
Extrapyramidal disorder 30.72 10.14 12 213703 20738 70693991
Haemoptysis 30.54 10.14 262 213453 51190 70663539
Poisoning 30.46 10.14 15 213700 22607 70692122
Respiratory tract inflammation 30.41 10.14 23 213692 812 70713917
Respiratory tract irritation 30.34 10.14 20 213695 565 70714164
Hyperbilirubinaemia 30.34 10.14 15 213700 22553 70692176
Altered state of consciousness 30.27 10.14 46 213669 39976 70674753
Morbid thoughts 30.17 10.14 22 213693 734 70713995
Quality of life decreased 30.16 10.14 74 213641 8421 70706308
Pharyngitis streptococcal 30.11 10.14 79 213636 9369 70705360
Osteoporosis 30.06 10.14 251 213464 48656 70666073
Airway remodelling 30.05 10.14 14 213701 195 70714534
Panic attack 29.83 10.14 139 213576 21980 70692749
Urticaria chronic 29.81 10.14 19 213696 506 70714223
Acute hepatic failure 29.50 10.14 24 213691 27648 70687081
Swollen tongue 29.46 10.14 202 213513 36844 70677885
Spirometry abnormal 29.45 10.14 21 213694 676 70714053
Sputum culture positive 29.38 10.14 43 213672 3311 70711418
Forced expiratory flow decreased 29.37 10.14 15 213700 258 70714471
Palpitations 29.35 10.14 483 213232 110270 70604459
Pharyngeal swelling 29.34 10.14 62 213653 6391 70708338
Polyp 29.32 10.14 66 213649 7104 70707625
Hepatic encephalopathy 29.28 10.14 15 213700 22103 70692626
Drug reaction with eosinophilia and systemic symptoms 29.26 10.14 84 213631 57929 70656800
Osteonecrosis of jaw 29.24 10.14 49 213666 40953 70673776
Cardiac murmur 29.23 10.14 92 213623 12094 70702635
Cytopenia 29.20 10.14 8 213707 17315 70697414
Intentional product misuse 29.04 10.14 132 213583 79463 70635266
Infection susceptibility increased 28.98 10.14 40 213675 2917 70711812
Ischaemic stroke 28.98 10.14 30 213685 30790 70683939
Neuropathy peripheral 28.80 10.14 244 213471 126652 70588077
Unresponsive to stimuli 28.60 10.14 72 213643 51859 70662870
Nephropathy toxic 28.60 10.14 10 213705 18504 70696225
Inflammation 28.37 10.14 131 213584 78534 70636195
Hereditary angioedema 28.29 10.14 53 213662 5006 70709723
Fear 28.23 10.14 131 213584 20680 70694049
FEV1/FVC ratio decreased 28.10 10.14 13 213702 178 70714551
Total lung capacity abnormal 28.10 10.14 13 213702 178 70714551
Lung diffusion test decreased 28.09 10.14 26 213689 1219 70713510
Type 2 diabetes mellitus 28.04 10.14 228 213487 43852 70670877
Accidental overdose 27.90 10.14 39 213676 35082 70679647
Nocturnal fear 27.90 10.14 7 213708 9 70714720
Sinus operation 27.63 10.14 32 213683 1955 70712774
Increased bronchial secretion 27.59 10.14 40 213675 3053 70711676
Mite allergy 27.58 10.14 22 213693 841 70713888
Lymphocyte count decreased 27.53 10.14 56 213659 43483 70671246
Clostridium difficile colitis 27.51 10.14 28 213687 28968 70685761
Gamma-glutamyltransferase increased 27.36 10.14 71 213644 50614 70664115
Influenza like illness 27.21 10.14 309 213406 65022 70649707
Hysterectomy 26.78 10.14 55 213660 5557 70709172
Haematochezia 26.78 10.14 121 213594 72960 70641769
Self-injurious ideation 26.67 10.14 41 213674 3297 70711432
Cerebral infarction 26.62 10.14 56 213659 42953 70671776
Gastrointestinal disorder 26.57 10.14 197 213518 105230 70609499
Hypercalcaemia 26.51 10.14 39 213676 34346 70680383
Fluid retention 26.49 10.14 300 213415 63085 70651644
Condition aggravated 26.47 10.14 1037 212678 426598 70288131
Infusion site swelling 26.41 10.14 58 213657 6140 70708589
Prostate cancer 26.40 10.14 33 213682 31130 70683599
Infusion site pruritus 26.21 10.14 40 213675 3197 70711532
Forced expiratory volume abnormal 26.16 10.14 11 213704 118 70714611
Eye disorder 26.14 10.14 128 213587 20657 70694072
Neurosensory hypoacusis 26.13 10.14 13 213702 211 70714518
Renal tubular necrosis 26.10 10.14 19 213696 23152 70691577
Proteinuria 26.06 10.14 30 213685 29344 70685385
Diabetic ketoacidosis 26.04 10.14 34 213681 31478 70683251
Orthostatic hypotension 26.04 10.14 75 213640 51668 70663061
Vomiting 26.04 10.14 1492 212223 591619 70123110
Tubulointerstitial nephritis 26.01 10.14 37 213678 33039 70681690
Lung disorder 26.01 10.14 322 213393 69162 70645567
Bacteraemia 25.93 10.14 30 213685 29279 70685450
Haematemesis 25.84 10.14 69 213646 48728 70666001
Respiratory arrest 25.83 10.14 80 213635 53853 70660876
Progressive multifocal leukoencephalopathy 25.48 10.14 13 213702 19201 70695528
Metastases to lung 25.30 10.14 9 213706 16475 70698254
Status epilepticus 25.25 10.14 22 213693 24504 70690225
Weight increased 25.24 10.14 930 212785 241401 70473328
Nausea 25.23 10.14 2218 211497 849870 69864859
Peritonitis 25.12 10.14 25 213690 26134 70688595
COVID-19 25.05 10.14 453 213262 105304 70609425
Enuresis 24.98 10.14 37 213678 2880 70711849
Lip swelling 24.93 10.14 182 213533 33872 70680857
Obsessive-compulsive disorder 24.89 10.14 52 213663 5318 70709411
Hypocalcaemia 24.86 10.14 62 213653 44797 70669932
Skin necrosis 24.82 10.14 9 213706 16282 70698447
Atrioventricular block first degree 24.79 10.14 3 213712 11670 70703059
Cognitive disorder 24.76 10.14 97 213618 60859 70653870
Myelodysplastic syndrome 24.75 10.14 32 213683 29753 70684976
Colitis ulcerative 24.70 10.14 40 213675 33883 70680846
Stevens-Johnson syndrome 24.61 10.14 44 213671 35863 70678866
Sinus bradycardia 24.55 10.14 21 213694 23602 70691127
Snoring 24.52 10.14 49 213666 4855 70709874
Eosinophilic pneumonia 24.51 10.14 49 213666 4856 70709873
Shock haemorrhagic 24.39 10.14 12 213703 18094 70696635
Attention deficit hyperactivity disorder 24.31 10.14 37 213678 2950 70711779
Cardiac disorder 24.28 10.14 280 213435 59135 70655594
Haemodialysis 24.17 10.14 11 213704 17355 70697374
Asthenia 24.12 10.14 1130 212585 456536 70258193
Haematuria 24.05 10.14 104 213611 63469 70651260
Incorrect dose administered 24.04 10.14 307 213408 66412 70648317
Live birth 23.91 10.14 6 213709 13773 70700956
Attention-seeking behaviour 23.89 10.14 10 213705 106 70714623
Immune reconstitution inflammatory syndrome 23.85 10.14 5 213710 12985 70701744
Inappropriate schedule of product administration 23.85 10.14 456 213259 107099 70607630
Oropharyngeal discomfort 23.79 10.14 55 213660 6024 70708705
Neurodevelopmental disorder 23.77 10.14 8 213707 43 70714686
Jaundice 23.52 10.14 75 213640 50033 70664696
Blebitis 23.38 10.14 6 213709 9 70714720
Asthma exercise induced 23.32 10.14 10 213705 113 70714616
Injection site scab 23.22 10.14 14 213701 337 70714392
Pulmonary pain 22.86 10.14 39 213676 3423 70711306
Homicidal ideation 22.70 10.14 38 213677 3285 70711444
Pneumothorax spontaneous 22.62 10.14 24 213691 1329 70713400
Atrial fibrillation 22.57 10.14 405 213310 183943 70530786
Allergy test positive 22.53 10.14 15 213700 431 70714298
Haemorrhage intracranial 22.31 10.14 25 213690 24752 70689977
Suicidal behaviour 22.29 10.14 36 213679 3020 70711709
Upper limb fracture 22.26 10.14 102 213613 16017 70698712
Lymphopenia 22.12 10.14 30 213685 27329 70687400
Cortisol decreased 22.09 10.14 28 213687 1879 70712850
NPM1 gene mutation 22.08 10.14 10 213705 130 70714599
Thinking abnormal 21.93 10.14 83 213632 11968 70702761
Swelling 21.90 10.14 418 213297 188121 70526608
Injection site pruritus 21.89 10.14 197 213518 39013 70675716
Exposure to allergen 21.79 10.14 12 213703 242 70714487
Appetite disorder 21.79 10.14 58 213657 6937 70707792
Oesophageal polyp 21.76 10.14 8 213707 58 70714671
Dysarthria 21.75 10.14 105 213610 62208 70652521
Ejection fraction decreased 21.72 10.14 37 213678 30725 70684004
Drug-induced liver injury 21.72 10.14 91 213624 56022 70658707
Ligament pain 21.66 10.14 12 213703 245 70714484
Epidural lipomatosis 21.62 10.14 20 213695 937 70713792
Joint range of motion decreased 21.59 10.14 28 213687 25998 70688731
Emotional disorder 21.57 10.14 88 213627 13138 70701591
Posterior reversible encephalopathy syndrome 21.56 10.14 25 213690 24377 70690352
Torsade de pointes 21.54 10.14 14 213701 18102 70696627
Endocarditis fibroplastica 21.38 10.14 6 213709 15 70714714
Blood alkaline phosphatase increased 21.37 10.14 97 213618 58424 70656305
Choking sensation 21.33 10.14 39 213676 3616 70711113
Febrile bone marrow aplasia 21.24 10.14 5 213710 11986 70702743
Electrolyte imbalance 21.17 10.14 30 213685 26831 70687898
Miosis 21.13 10.14 8 213707 14093 70700636
Hypoalbuminaemia 21.12 10.14 16 213699 19106 70695623
Ulcer 21.06 10.14 28 213687 25726 70689003
Urinary retention 21.06 10.14 84 213631 52436 70662293
Acute generalised exanthematous pustulosis 21.05 10.14 10 213705 15387 70699342
Pulmonary renal syndrome 21.03 10.14 16 213699 570 70714159
Chest pain 21.02 10.14 942 212773 250318 70464411
Ocular discomfort 21.01 10.14 43 213672 4334 70710395
Injection site pain 20.97 10.14 483 213232 117136 70597593
Subarachnoid haemorrhage 20.69 10.14 17 213698 19487 70695242
Increased upper airway secretion 20.65 10.14 39 213676 3706 70711023
Female genital tract fistula 20.55 10.14 35 213680 3068 70711661
Nasal discomfort 20.54 10.14 45 213670 4756 70709973
Atrioventricular block complete 20.50 10.14 10 213705 15153 70699576
Blood immunoglobulin G decreased 20.49 10.14 34 213681 2918 70711811
Nasal mucosal disorder 20.41 10.14 13 213702 346 70714383
Myoclonus 20.21 10.14 30 213685 26325 70688404
Inhibitory drug interaction 20.20 10.14 39 213676 3768 70710961
Metastases to central nervous system 20.20 10.14 10 213705 15024 70699705
Pulmonary arterial hypertension 20.15 10.14 43 213672 32812 70681917
Mental disorder 20.14 10.14 150 213565 28090 70686639
Coagulopathy 19.99 10.14 44 213671 33205 70681524
Hyposmia 19.98 10.14 16 213699 615 70714114
Neuropsychiatric symptoms 19.95 10.14 20 213695 1036 70713693
Schizophrenia 19.88 10.14 13 213702 16755 70697974
Venoocclusive liver disease 19.84 10.14 4 213711 10674 70704055
Drug tolerance decreased 19.76 10.14 3 213712 9830 70704899
Electrocardiogram QRS complex prolonged 19.69 10.14 3 213712 9803 70704926
Hepatitis C 19.64 10.14 7 213708 12800 70701929
Chronic kidney disease 19.54 10.14 106 213609 60951 70653778
Vasculitis 19.50 10.14 113 213602 19445 70695284
Lactose intolerance 19.39 10.14 28 213687 2130 70712599
Injection site movement impairment 19.26 10.14 6 213709 24 70714705
Tenosynovitis 19.23 10.14 9 213706 13967 70700762
Poisoning deliberate 19.20 10.14 14 213701 17046 70697683
Sputum retention 19.20 10.14 19 213696 969 70713760
Adrenal suppression 19.18 10.14 22 213693 1330 70713399
Pathogen resistance 19.14 10.14 8 213707 13271 70701458
Liver function test abnormal 19.11 10.14 107 213608 61039 70653690
Ejection fraction abnormal 19.04 10.14 25 213690 1738 70712991
Pigment dispersion syndrome 18.88 10.14 6 213709 26 70714703
Emotional distress 18.83 10.14 183 213532 37005 70677724
Oliguria 18.77 10.14 11 213704 15040 70699689
Embolism venous 18.73 10.14 38 213677 3807 70710922
Hip arthroplasty 18.65 10.14 35 213680 28005 70686724
Prothrombin time prolonged 18.59 10.14 13 213702 16177 70698552
Cytomegalovirus viraemia 18.59 10.14 6 213709 11679 70703050
Hallucination 18.54 10.14 328 213387 75932 70638797
Obesity 18.42 10.14 141 213574 26630 70688099
CFTR gene mutation 18.38 10.14 8 213707 94 70714635
Airway peak pressure increased 18.36 10.14 12 213703 334 70714395
Sleep talking 18.36 10.14 19 213696 1022 70713707
Encephalitis 18.30 10.14 9 213706 13576 70701153
Intestinal perforation 18.27 10.14 13 213702 16031 70698698
Subdural haematoma 18.25 10.14 38 213677 29260 70685469
Upper airway obstruction 18.23 10.14 21 213694 1275 70713454
Allergic sinusitis 18.20 10.14 14 213701 507 70714222
Haemophilus infection 18.17 10.14 26 213689 1961 70712768
Eye paraesthesia 18.16 10.14 8 213707 97 70714632
Dysphemia 18.02 10.14 34 213681 3229 70711500
Injection site hypoaesthesia 17.98 10.14 13 213702 428 70714301
Pharyngeal oedema 17.87 10.14 94 213621 15602 70699127
Sputum abnormal 17.87 10.14 19 213696 1055 70713674
Panniculitis 17.86 10.14 5 213710 10671 70704058
Lung hernia 17.82 10.14 7 213708 62 70714667
Infection 17.80 10.14 491 213224 210294 70504435
Intervertebral disc degeneration 17.76 10.14 86 213629 13814 70700915
Transaminases increased 17.73 10.14 77 213638 46941 70667788
Oxygen saturation decreased 17.73 10.14 468 213247 115961 70598768
Fall 17.71 10.14 1127 212588 442969 70271760
Muscle rigidity 17.71 10.14 18 213697 18632 70696097
Hallucination, auditory 17.70 10.14 105 213610 18223 70696506
Upper gastrointestinal haemorrhage 17.65 10.14 56 213659 37421 70677308
Gluten sensitivity 17.63 10.14 12 213703 358 70714371
Muscle spasticity 17.58 10.14 20 213695 19669 70695060
Basal cell carcinoma 17.58 10.14 48 213667 33650 70681079
Syncope 17.56 10.14 373 213342 165336 70549393
Child abuse 17.54 10.14 12 213703 361 70714368
Blood lactic acid 17.41 10.14 13 213702 450 70714279
Paraesthesia oral 17.33 10.14 92 213623 15325 70699404
Frequent bowel movements 17.30 10.14 23 213692 21130 70693599
Shock 17.28 10.14 63 213652 40362 70674367
Infusion site erythema 17.26 10.14 56 213659 7479 70707250
Toxic encephalopathy 17.18 10.14 5 213710 10401 70704328
Meningitis eosinophilic 17.15 10.14 5 213710 15 70714714
Pulmonary artery stenosis congenital 17.15 10.14 5 213710 15 70714714
Knee arthroplasty 17.05 10.14 50 213665 34251 70680478
Sputum purulent 17.03 10.14 20 213695 1240 70713489
Acidosis 16.92 10.14 18 213697 18245 70696484
Glucose tolerance impaired 16.89 10.14 52 213663 6754 70707975
Psoriatic arthropathy 16.82 10.14 120 213595 64651 70650078
Tachycardia 16.76 10.14 357 213358 158189 70556540
Urinary tract infection 16.76 10.14 597 213118 248172 70466557
Ligament sprain 16.74 10.14 76 213639 11887 70702842
Functional residual capacity increased 16.74 10.14 7 213708 74 70714655
Brain oedema 16.69 10.14 28 213687 23390 70691339
Blood potassium increased 16.56 10.14 36 213679 27290 70687439
Glomerular filtration rate decreased 16.54 10.14 23 213692 20733 70693996
Hypercapnia 16.53 10.14 59 213656 8270 70706459
Medication error 16.50 10.14 102 213613 56810 70657919
Hyperkaliuria 16.50 10.14 9 213706 178 70714551
Toxic skin eruption 16.41 10.14 22 213693 20140 70694589
Oesophageal carcinoma 16.41 10.14 4 213711 9362 70705367
Ileus 16.34 10.14 30 213685 24207 70690522
Injection site urticaria 16.34 10.14 74 213641 11564 70703165
Pulmonary thrombosis 16.28 10.14 72 213643 11136 70703593
Joint stiffness 16.26 10.14 53 213662 35123 70679606
Allergic respiratory disease 16.26 10.14 7 213708 80 70714649
Blood lactate dehydrogenase increased 16.19 10.14 53 213662 35074 70679655
Ankle fracture 16.19 10.14 90 213625 15254 70699475
Drug ineffective 16.09 10.14 2537 211178 937215 69777514
Mobility decreased 16.09 10.14 216 213499 102783 70611946
Endocarditis 16.04 10.14 5 213710 9949 70704780
Panic reaction 16.02 10.14 38 213677 4233 70710496
Splenomegaly 15.96 10.14 20 213695 18850 70695879
Hospitalisation 15.96 10.14 343 213372 82225 70632504
Seizure 15.95 10.14 411 213304 177551 70537178
Blood calcium decreased 15.88 10.14 40 213675 28806 70685923
Proctalgia 15.87 10.14 3 213712 8380 70706349
Sarcoidosis 15.87 10.14 50 213665 6577 70708152
Prescribed underdose 15.77 10.14 25 213690 21360 70693369
Klebsiella infection 15.73 10.14 12 213703 14280 70700449
Gangrene 15.67 10.14 3 213712 8306 70706423
Hemiparesis 15.55 10.14 46 213669 31423 70683306
Bronchiolitis obliterans syndrome 15.44 10.14 10 213705 274 70714455
Mucosal discolouration 15.37 10.14 15 213700 752 70713977
Product taste abnormal 15.36 10.14 25 213690 2111 70712618
Pulmonary oedema 15.35 10.14 166 213549 82112 70632617
Aortic valve stenosis 15.33 10.14 41 213674 4918 70709811
Drug eruption 15.31 10.14 64 213651 39432 70675297
Drug use disorder 15.25 10.14 3 213712 8148 70706581
Hypohidrosis 15.25 10.14 10 213705 280 70714449
Catatonia 15.21 10.14 3 213712 8130 70706599
Rectal haemorrhage 15.19 10.14 126 213589 65705 70649024
Chimerism 15.19 10.14 10 213705 282 70714447
Depressive symptom 15.18 10.14 42 213673 5139 70709590
Hepatic cirrhosis 15.13 10.14 45 213670 30686 70684043
Enterococcal infection 15.11 10.14 13 213702 14569 70700160
Breast neoplasm 15.08 10.14 16 213699 886 70713843
Femur fracture 14.99 10.14 57 213658 36075 70678654
Aplastic anaemia 14.91 10.14 17 213698 16699 70698030
Peripheral sensory neuropathy 14.89 10.14 9 213706 12101 70702628
Ileus paralytic 14.85 10.14 4 213711 8757 70705972
Fracture pain 14.83 10.14 11 213704 377 70714352
Respiratory failure 14.78 10.14 391 213324 168344 70546385
Diaphragmatic disorder 14.77 10.14 21 213694 1575 70713154
Hypertensive crisis 14.70 10.14 22 213693 19240 70695489
Inappropriate antidiuretic hormone secretion 14.66 10.14 30 213685 23246 70691483
Ataxia 14.56 10.14 30 213685 23187 70691542
Adenotonsillectomy 14.55 10.14 6 213709 61 70714668
Delusion 14.52 10.14 22 213693 19143 70695586
Osteomyelitis 14.49 10.14 45 213670 30273 70684456
Body temperature abnormal 14.45 10.14 23 213692 1906 70712823
Pigmentary glaucoma 14.42 10.14 3 213712 0 70714729
Sleep study abnormal 14.42 10.14 3 213712 0 70714729
Benign prostatic hyperplasia 14.36 10.14 66 213649 10377 70704352
Kidney transplant rejection 14.36 10.14 6 213709 9955 70704774
Laryngospasm 14.30 10.14 33 213682 3610 70711119
Gastric haemorrhage 14.27 10.14 13 213702 14172 70700557
School refusal 14.26 10.14 5 213710 31 70714698
Peak expiratory flow rate increased 14.25 10.14 4 213711 10 70714719
Therapeutic response unexpected 14.25 10.14 99 213616 18132 70696597
Gastroenteritis viral 14.20 10.14 112 213603 21343 70693386
Bronchopulmonary aspergillosis 14.16 10.14 26 213689 20976 70693753
Dialysis 14.15 10.14 19 213696 17383 70697346
Nasal septum deviation 14.14 10.14 21 213694 1638 70713091
Spinal operation 14.14 10.14 50 213665 6978 70707751
Colorectal cancer 14.11 10.14 4 213711 8466 70706263
Muscle tension dysphonia 14.06 10.14 6 213709 67 70714662
Tachypnoea 14.05 10.14 42 213673 28596 70686133
Vasomotor rhinitis 13.99 10.14 7 213708 115 70714614
Pyrexia 13.89 10.14 1609 212106 605343 70109386
Eosinophil count abnormal 13.86 10.14 13 213702 620 70714109
Paranasal sinus discomfort 13.85 10.14 32 213683 3503 70711226
Acute pulmonary oedema 13.84 10.14 12 213703 13400 70701329
Cushingoid 13.83 10.14 56 213659 8332 70706397
Growth retardation 13.83 10.14 21 213694 1671 70713058
Bronchitis chronic 13.78 10.14 35 213680 4069 70710660
Blood parathyroid hormone decreased 13.72 10.14 5 213710 9019 70705710
Cystic fibrosis respiratory infection suppression 13.71 10.14 11 213704 424 70714305
Vocal cord disorder 13.70 10.14 19 213696 1392 70713337
Hepatic cancer 13.69 10.14 6 213709 9677 70705052
Serum ferritin increased 13.68 10.14 5 213710 9000 70705729
Anaphylactic shock 13.67 10.14 154 213561 32336 70682393
Expiratory reserve volume decreased 13.60 10.14 6 213709 73 70714656
Prostatomegaly 13.58 10.14 30 213685 3189 70711540
Abortion 13.57 10.14 18 213697 1264 70713465
Pneumococcal infection 13.56 10.14 15 213700 871 70713858
Dizziness exertional 13.49 10.14 12 213703 534 70714195
Abdominal pain lower 13.40 10.14 42 213673 28174 70686555
Nodular vasculitis 13.40 10.14 5 213710 38 70714691
Pneumonia viral 13.39 10.14 55 213660 8237 70706492
Ear swelling 13.33 10.14 19 213696 1428 70713301
Oesophagogastroduodenoscopy 13.33 10.14 8 213707 191 70714538
Bronchiolitis 13.30 10.14 33 213682 3781 70710948
Vaccination site swelling 13.28 10.14 5 213710 39 70714690
Decreased activity 13.27 10.14 52 213663 7622 70707107
Injection site swelling 13.26 10.14 193 213522 42964 70671765
Breast conserving surgery 13.20 10.14 13 213702 659 70714070
Febrile convulsion 13.19 10.14 15 213700 898 70713831
Obsessive thoughts 13.18 10.14 16 213699 1027 70713702
Fatigue 13.14 10.14 2742 210973 821577 69893152
Duodenal ulcer 13.13 10.14 16 213699 15264 70699465
Otorrhoea 13.11 10.14 20 213695 1598 70713131
Distal intestinal obstruction syndrome 13.10 10.14 13 213702 665 70714064
Body mass index increased 13.10 10.14 21 213694 1751 70712978
Functional residual capacity decreased 13.05 10.14 6 213709 81 70714648
Laryngeal stenosis 13.05 10.14 15 213700 909 70713820
Acute sinusitis 13.05 10.14 35 213680 4206 70710523
Hand fracture 13.04 10.14 41 213674 5386 70709343
Leukoencephalopathy 13.00 10.14 3 213712 7291 70707438
Premature delivery 12.96 10.14 28 213687 21276 70693453
Self esteem decreased 12.93 10.14 15 213700 918 70713811
Adjustment disorder 12.92 10.14 29 213686 3115 70711614
Bladder cancer 12.86 10.14 20 213695 17222 70697507
COVID-19 immunisation 12.76 10.14 16 213699 1062 70713667
Infusion site haemorrhage 12.75 10.14 27 213688 2788 70711941
Cardiac tamponade 12.68 10.14 5 213710 8590 70706139
Crepitations 12.68 10.14 56 213659 8658 70706071
Mandibular mass 12.66 10.14 8 213707 210 70714519
Lymphostasis 12.65 10.14 4 213711 17 70714712
Graft versus host disease 12.63 10.14 16 213699 15007 70699722
Gallbladder disorder 12.58 10.14 94 213621 17618 70697111
Haematocrit decreased 12.58 10.14 111 213604 57147 70657582
Urosepsis 12.58 10.14 34 213681 23915 70690814
Product appearance confusion 12.57 10.14 5 213710 46 70714683
Unintentional medical device removal 12.56 10.14 3 213712 7121 70707608
Hyperplastic cholecystopathy 12.50 10.14 7 213708 146 70714583
Cephalo-pelvic disproportion 12.50 10.14 7 213708 146 70714583
Hypernatraemia 12.48 10.14 12 213703 12749 70701980
Nocturnal dyspnoea 12.42 10.14 18 213697 1373 70713356
Myositis 12.38 10.14 21 213694 17468 70697261
Fight in school 12.35 10.14 3 213712 3 70714726
Platelet adhesiveness decreased 12.35 10.14 3 213712 3 70714726
Chronic rhinosinusitis with nasal polyps 12.35 10.14 3 213712 3 70714726
Upper airway resistance syndrome 12.35 10.14 3 213712 3 70714726
Allergy to fermented products 12.35 10.14 3 213712 3 70714726
Upper respiratory tract congestion 12.35 10.14 24 213691 2330 70712399
Constipation 12.34 10.14 628 213087 251810 70462919
Pregnancy 12.31 10.14 34 213681 23747 70690982
Defiant behaviour 12.29 10.14 4 213711 19 70714710
Autophobia 12.29 10.14 4 213711 19 70714710
Cold agglutinins positive 12.29 10.14 5 213710 49 70714680
Uveitis 12.28 10.14 16 213699 14829 70699900
Photosensitivity reaction 12.28 10.14 100 213615 19240 70695489
Tumour lysis syndrome 12.24 10.14 29 213686 21331 70693398
Epstein-Barr virus infection 12.23 10.14 13 213702 13185 70701544
Parkinsonism 12.19 10.14 17 213698 15308 70699421
Injection site rash 12.18 10.14 88 213627 16322 70698407
Flushing 12.13 10.14 329 213386 81843 70632886
Diverticulum oesophageal 12.13 10.14 7 213708 155 70714574
Benign renal neoplasm 12.12 10.14 4 213711 20 70714709
Myalgia 12.03 10.14 620 213095 167272 70547457
Onychophagia 12.03 10.14 6 213709 98 70714631
Gastric cancer 11.96 10.14 6 213709 8949 70705780
Device related infection 11.96 10.14 53 213662 32132 70682597
Dermatitis acneiform 11.94 10.14 6 213709 8939 70705790
Hepatic cytolysis 11.87 10.14 25 213690 19167 70695562
Hepatitis 11.83 10.14 95 213620 49885 70664844
Nasal pruritus 11.79 10.14 10 213705 417 70714312
Lung opacity 11.78 10.14 31 213684 3682 70711047
Hypothermia 11.77 10.14 28 213687 20566 70694163
Head banging 11.77 10.14 11 213704 522 70714207
Gastroenteritis eosinophilic 11.77 10.14 8 213707 238 70714491
Ventricular fibrillation 11.75 10.14 42 213673 27069 70687660
Conjunctivitis allergic 11.75 10.14 16 213699 1152 70713577
Animal scratch 11.73 10.14 16 213699 1154 70713575
Arthralgia 11.69 10.14 1333 212382 502057 70212672
Respiratory fume inhalation disorder 11.67 10.14 7 213708 167 70714562
Fibromyalgia 11.66 10.14 206 213509 47668 70667061
Blood phosphorus increased 11.65 10.14 3 213712 6767 70707962
Granulocytopenia 11.64 10.14 9 213706 10638 70704091
Product availability issue 11.62 10.14 27 213688 2967 70711762
Steroid diabetes 11.60 10.14 27 213688 2970 70711759
Product container issue 11.60 10.14 15 213700 1027 70713702
Injection site eczema 11.55 10.14 5 213710 58 70714671
Epilepsy 11.51 10.14 69 213646 38715 70676014
Hypovolaemia 11.51 10.14 19 213696 15974 70698755
Mental status changes 11.49 10.14 128 213587 62973 70651756
Abnormal weight gain 11.48 10.14 23 213692 2283 70712446
Muscular weakness 11.48 10.14 323 213392 138013 70576716
Dyskinesia oesophageal 11.47 10.14 5 213710 59 70714670
Hyperglycaemia 11.46 10.14 132 213583 64540 70650189
Gastric ulcer 11.42 10.14 53 213662 31737 70682992
Lip discolouration 11.41 10.14 12 213703 658 70714071
Bradyphrenia 11.40 10.14 8 213707 9938 70704791
Oral allergy syndrome 11.40 10.14 5 213710 60 70714669
Measles 11.35 10.14 9 213706 341 70714388
Ankylosing spondylitis 11.33 10.14 11 213704 11635 70703094
Autism spectrum disorder 11.29 10.14 15 213700 1055 70713674
Bone density decreased 11.25 10.14 66 213649 11408 70703321
Faecaloma 11.22 10.14 9 213706 10442 70704287
BK virus infection 11.22 10.14 5 213710 7984 70706745
Blood albumin decreased 11.19 10.14 32 213683 22095 70692634
Sinus pain 11.18 10.14 27 213688 3042 70711687
Vaccination site pain 11.17 10.14 6 213709 115 70714614
Coronary artery disease 11.14 10.14 128 213587 62608 70652121
Bronchitis viral 11.12 10.14 15 213700 1070 70713659
Small airways disease 11.12 10.14 4 213711 27 70714702
Choking 11.09 10.14 64 213651 10996 70703733
Drug level decreased 11.08 10.14 13 213702 12611 70702118
Graft versus host disease in lung 11.06 10.14 13 213702 807 70713922
Lower gastrointestinal haemorrhage 11.05 10.14 17 213698 14703 70700026
Neutrophilia 10.98 10.14 4 213711 7217 70707512
Miller Fisher syndrome 10.93 10.14 7 213708 188 70714541
Mycotic allergy 10.92 10.14 15 213700 1089 70713640
Enterocolitis 10.90 10.14 14 213701 13052 70701677
Hyperammonaemia 10.88 10.14 9 213706 10284 70704445
Blood immunoglobulin E abnormal 10.88 10.14 4 213711 29 70714700
Violence-related symptom 10.81 10.14 12 213703 700 70714029
Renal injury 10.78 10.14 20 213695 16074 70698655
Sinus headache 10.76 10.14 34 213681 4479 70710250
Hiatus hernia 10.70 10.14 104 213611 21030 70693699
Drug ineffective for unapproved indication 10.70 10.14 70 213645 38468 70676261
Anticholinergic syndrome 10.62 10.14 26 213689 2954 70711775
Hypervolaemia 10.58 10.14 73 213642 39633 70675096
Anal abscess 10.58 10.14 6 213709 8352 70706377
Pertussis 10.57 10.14 13 213702 846 70713883
Systemic inflammatory response syndrome 10.56 10.14 10 213705 10702 70704027
Injection site erythema 10.49 10.14 291 213424 72633 70642096
Neurogenic shock 10.49 10.14 11 213704 601 70714128
Hemiplegia 10.48 10.14 16 213699 13879 70700850
Duodenitis 10.45 10.14 4 213711 6998 70707731
Enteritis 10.44 10.14 14 213701 12817 70701912
Occupational exposure to dust 10.43 10.14 4 213711 33 70714696
Akathisia 10.43 10.14 13 213702 12280 70702449
Concussion 10.41 10.14 52 213663 8457 70706272
Bacterial sepsis 10.40 10.14 5 213710 7642 70707087
Squamous cell carcinoma of the oral cavity 10.40 10.14 10 213705 492 70714237
Reaction to excipient 10.40 10.14 17 213698 1441 70713288
Laryngitis fungal 10.35 10.14 6 213709 134 70714595
Foot deformity 10.35 10.14 30 213685 20625 70694104
Tearfulness 10.34 10.14 36 213679 4984 70709745
Hyperventilation 10.32 10.14 46 213669 7140 70707589
Cardiac failure congestive 10.31 10.14 320 213395 135137 70579592
Laziness 10.30 10.14 12 213703 738 70713991
Blood immunoglobulin E 10.29 10.14 3 213712 9 70714720
Suspected suicide 10.27 10.14 7 213708 8827 70705902
Red blood cell count decreased 10.23 10.14 104 213611 52057 70662672
Oral pruritus 10.22 10.14 20 213695 1951 70712778
Decreased interest 10.19 10.14 28 213687 3413 70711316
Prescribed overdose 10.18 10.14 126 213589 27055 70687674
Acute coronary syndrome 10.18 10.14 29 213686 20050 70694679

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC R03DC03 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
Leukotriene receptor antagonists
ATC R03DC53 RESPIRATORY SYSTEM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
Leukotriene receptor antagonists
FDA MoA N0000000083 Leukotriene Receptor Antagonists
MeSH PA D018927 Anti-Asthmatic Agents
MeSH PA D065694 Cytochrome P-450 CYP1A2 Inducers
MeSH PA D006727 Hormone Antagonists
MeSH PA D020024 Leukotriene Antagonists
MeSH PA D065606 Metabolic Side Effects of Drugs and Substances
MeSH PA D019141 Respiratory System Agents
FDA EPC N0000175777 Leukotriene Receptor Antagonist
CHEBI has role CHEBI:38070 antiarrhythmic agent
CHEBI has role CHEBI:49159 leukotriene antagonists
CHEBI has role CHEBI:49167 anti-asthmatic drugs

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Allergic rhinitis indication 61582004
Non-allergic asthma indication 266361008 DOID:9360
Allergic asthma indication 389145006 DOID:9415
Asthma management indication 406162001
Exercise-Induced Bronchospasm Prevention indication
Suicidal thoughts contraindication 6471006
Hallucinations contraindication 7011001
Mood swings contraindication 18963009
Feeling agitated contraindication 24199005
Depressive disorder contraindication 35489007
Anxiety contraindication 48694002
Vasculitis of the skin contraindication 53312001
Dream disorder contraindication 85418005
Eosinophil count raised contraindication 386789004
Tremors contraindication
Nervousness contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.28 acidic
pKa2 4.98 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Cysteinyl leukotriene receptor 1 GPCR ANTAGONIST Ki 9.30 CHEMBL CHEMBL
Alpha-2A adrenergic receptor GPCR Ki 5.83 DRUG MATRIX
Sodium-dependent noradrenaline transporter Transporter Ki 5.57 DRUG MATRIX
5-hydroxytryptamine receptor 2B GPCR Ki 5.40 DRUG MATRIX
D(3) dopamine receptor GPCR Ki 5.58 DRUG MATRIX
Muscarinic acetylcholine receptor M1 GPCR Ki 5.71 DRUG MATRIX
Muscarinic acetylcholine receptor M3 GPCR Ki 5.85 DRUG MATRIX
Beta-3 adrenergic receptor GPCR Ki 5.50 DRUG MATRIX
Alpha-2C adrenergic receptor GPCR Ki 6.12 DRUG MATRIX
Sodium-dependent dopamine transporter Transporter Ki 5.69 DRUG MATRIX
Adenosine receptor A3 GPCR Ki 6.61 DRUG MATRIX
Cytochrome P450 2C8 Enzyme Ki 5.96 WOMBAT-PK
Delta-type opioid receptor GPCR Ki 5.77 DRUG MATRIX
Arachidonate 5-lipoxygenase Enzyme Ki 4.33 WOMBAT-PK
Epidermal growth factor receptor Kinase IC50 5.50 DRUG MATRIX
Tyrosine-protein kinase Fyn Kinase IC50 5.33 DRUG MATRIX
Thromboxane-A synthase Enzyme IC50 5.82 DRUG MATRIX
Cysteinyl leukotriene receptor 2 GPCR Ki 5.30 PDSP
Mitogen-activated protein kinase 14 Kinase IC50 6.07 DRUG MATRIX
Substance-K receptor GPCR Ki 5.90 DRUG MATRIX
Uracil nucleotide/cysteinyl leukotriene receptor GPCR Ki 5.18 CHEMBL
Beta-2 adrenergic receptor GPCR Ki 5.62 DRUG MATRIX
Cysteinyl leukotriene receptor 1 GPCR Ki 9.30 CHEMBL
Uracil nucleotide/cysteinyl leukotriene receptor GPCR ANTAGONIST IC50 7.21 IUPHAR

External reference:

IDSource
4024117 VUID
N0000022122 NUI
D00529 KEGG_DRUG
151767-02-1 SECONDARY_CAS_RN
4021110 VANDF
4024117 VANDF
C0298130 UMLSCUI
CHEBI:50730 CHEBI
MTK PDB_CHEM_ID
CHEMBL787 ChEMBL_ID
CHEMBL1200681 ChEMBL_ID
DB00471 DRUGBANK_ID
C093875 MESH_SUPPLEMENTAL_RECORD_UI
3340 IUPHAR_LIGAND_ID
7388 INN_ID
MHM278SD3E UNII
5281040 PUBCHEM_CID
115713 RXNORM
11578 MMSL
189710 MMSL
5134 MMSL
d04289 MMSL
007256 NDDF
007257 NDDF
108620002 SNOMEDCT_US
320883008 SNOMEDCT_US
373728005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0093-7487 GRANULE 4 mg ORAL ANDA 31 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0093-7487 GRANULE 4 mg ORAL ANDA 31 sections
MONTELUKAST HUMAN PRESCRIPTION DRUG LABEL 1 0143-9649 TABLET, FILM COATED 10 mg ORAL ANDA 25 sections
MONTELUKAST HUMAN PRESCRIPTION DRUG LABEL 1 0143-9650 TABLET, CHEWABLE 5 mg ORAL ANDA 25 sections
MONTELUKAST HUMAN PRESCRIPTION DRUG LABEL 1 0143-9651 TABLET, CHEWABLE 4 mg ORAL ANDA 25 sections
Montelukast HUMAN PRESCRIPTION DRUG LABEL 1 0781-5554 TABLET, CHEWABLE 4 mg ORAL ANDA 28 sections
Montelukast HUMAN PRESCRIPTION DRUG LABEL 1 0781-5555 TABLET, CHEWABLE 5 mg ORAL ANDA 28 sections
Montelukast HUMAN PRESCRIPTION DRUG LABEL 1 0781-5560 TABLET, FILM COATED 10 mg ORAL ANDA 28 sections
Montelukast HUMAN PRESCRIPTION DRUG LABEL 1 0904-6808 TABLET, FILM COATED 10 mg ORAL ANDA 28 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 13668-079 TABLET, CHEWABLE 4 mg ORAL ANDA 29 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 13668-079 TABLET, CHEWABLE 4 mg ORAL ANDA 29 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 13668-079 TABLET, CHEWABLE 4 mg ORAL ANDA 29 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 13668-080 TABLET, CHEWABLE 5 mg ORAL ANDA 29 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 13668-080 TABLET, CHEWABLE 5 mg ORAL ANDA 29 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 13668-080 TABLET, CHEWABLE 5 mg ORAL ANDA 29 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 13668-081 TABLET 10 mg ORAL ANDA 29 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 13668-081 TABLET 10 mg ORAL ANDA 29 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 13668-081 TABLET 10 mg ORAL ANDA 29 sections
MONTELUKAST SODIUM ORAL HUMAN PRESCRIPTION DRUG LABEL 1 13668-531 GRANULE 4 mg ORAL ANDA 19 sections
MONTELUKAST SODIUM ORAL HUMAN PRESCRIPTION DRUG LABEL 1 13668-531 GRANULE 4 mg ORAL ANDA 19 sections
MONTELUKAST SODIUM ORAL HUMAN PRESCRIPTION DRUG LABEL 1 13668-531 GRANULE 4 mg ORAL ANDA 19 sections
MONTELUKAST SODIUM ORAL HUMAN PRESCRIPTION DRUG LABEL 1 13668-531 GRANULE 4 mg ORAL ANDA 19 sections
Montelukast Sodium HUMAN PRESCRIPTION DRUG LABEL 1 16729-119 TABLET, FILM COATED 10 mg ORAL ANDA 28 sections
SINGULAIR HUMAN PRESCRIPTION DRUG LABEL 1 21695-221 TABLET, FILM COATED 10 mg ORAL NDA 28 sections
SINGULAIR HUMAN PRESCRIPTION DRUG LABEL 1 21695-565 TABLET, CHEWABLE 5 mg ORAL NDA 28 sections
MONTELUKAST SODIUM Human Prescription Drug Label 1 27241-015 GRANULE 4 mg ORAL ANDA 28 sections
MONTELUKAST SODIUM Human Prescription Drug Label 1 27241-016 TABLET, CHEWABLE 4 mg ORAL ANDA 28 sections
MONTELUKAST SODIUM Human Prescription Drug Label 1 27241-017 TABLET, CHEWABLE 5 mg ORAL ANDA 28 sections
MONTELUKAST SODIUM Human Prescription Drug Label 1 27241-018 TABLET, COATED 10 mg ORAL ANDA 28 sections
montelukast sodium HUMAN PRESCRIPTION DRUG LABEL 1 29300-220 TABLET, FILM COATED 10 mg ORAL ANDA 26 sections